Current Drug Shortages: Perflutren Lipid Microsphere (DEFINITY ) Injection
Wednesday, 28 March 2012 10:13
Acetylcysteine Inhalation Solution
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 100 mg/mL; 30 mL vial | Manufacturing delay. | Product 100 mg/mL; 30 mL vial (NDC 0409-3307-03): next delivery April.
Product 200 mg/mL; 30 mL vial (NDC 0409-3308-03): next delivery April.
Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Roxane Laboratories 1-614-276-4000 200 mg/mL, 10 mL (NDC 00054-3028-02), 200 mg/mL, 30 mL (NDC 00054-3026-02) | Manufacturing Delay | Roxane Laboratories has all acetylcysteine inhalation solution presentations on backorder and the company cannot provide an anticipate release date. | |
American Regent/Luitpold 631-924-4000 100 mg/mL, 4 mL (NDC 00517-7504-25), 100 mg/mL, 10 mL (NDC 00517-7510-03), 200 mg/mL, 4 mL (NDC 00517-7604-25), 200 mg/mL, 10 mL (NDC 00517-7610-03), 200 mg/mL, 30 mL (NDC 00517-7630-03) | Manufacturing delays | American Regent is releasing acetylcysteine inhalation solution as it becomes available. | Reverified 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Akorn Pharmaceuticals 1-800-932-5676 0.5 mg/ml; 2ml ampule (NDC 17478-0067-02) 0.5 mg/ml; 5ml ampule (NDC 17478-0067-05) | Increased demand | Limited emergency supply of Alfenta 2 mL and 5 mL ampules. 2 mL (NDC 17478-0067-02) due to release in April. 5 mL (NDC 17478-0067-05) due to release in April. | Revised 3/16/2012 |
Hospira, Inc. Customer Service: 1-877-946-7747 500 mcg/mL; 2 mL amp (NDC 0409-2266-02) 500 mcg/mL; 5 mL amp (NDC 0409-2266-05) | Material shortage (API). | Product 500 mcg/mL, 2 mL amp (NDC 0409-2266-02): next delivery May. Product 500 mcg/mL; 5 mL amp (NDC 0409-2266-05): next delivery May. Please check your wholesaler for all available inventory. | Reverified 3/20/2012 |
Company | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals | Manufacturing delays | Teva has amikacin 250 mg/mL 4 mL vials available for drop shipment (NDC 00703-9040-03). | Reverified 3/15/2012 |
Bedford Customer Service 1-800-562-4797 250 mg/mL, 2 mL vials (NDC 55390-0226-02) | Manufacturing delays | Bedford has all amikacin presentations on back order and the company cannot estimate a release date. |
For detailed clinical recommendations to use during this shortage, please see information posted by the American Society of Parenteral and Enteral Nutrition:
http://www.nutritioncare.org/Professional_Resources/Information_to_Use_in_the_Event_of_an_Intravenous_Amino_Acids_Shortage/
Company | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 Aminosyn II 10%, Sulfite-free; 1 L bag (NDC 0409-4164-05) Aminosyn 10%, Sulfite-free; 500 mL bag (NDC 0409-4191-03) Aminosyn 8.5%, Sulfite-free; 500 mL bag (NDC 0409-4187-03) Aminosyn II 10%; 2 L bag (NDC 0409-7121-07) Aminosyn II 15%, Sulfite-free; 2 L bag (NDC 0409-7171-17) Aminosyn 10%, Sulfite-free, 1 L (NDC 0409-4191-05) Aminosyn II 10%, 500 mL, Sulfite-free (NDC 0409-4164-03) Aminosyn HBC 7%, 500 mL, Sulfite-free (NDC 0409-4168-03) Aminosyn 3.5%, sulfite-free, 1 L (NDC 0409-4196-05) Aminosyn 8.5%, sulfite-free, 500 mL (NDC 0409-4187-03) Aminosyn 10%, sulfite-free, 500 mL (NDC 0409-4191-03) Aminosyn II 8.5%, sulfite-free, 500 mL (NDC 0409-4162-03) Aminosyn II 8.5% with electrolytes, sulfite-free, 500 mL (NDC 0409-4171-03) Aminosyn II 10%, sulfite-free, 1L (NDC 0409-4164-05) Aminosyn-PF 7%, sulfite-free, 500 mL (NDC 0409-4178-03) Aminosyn-PF 10%, 1000 mL, sulfite-free (NDC 0409-4179-05) Aminosyn RF 5.2%, 500 mL, sulfite-free (NDC 0409-4166-03) | Manufacturing delay; Higher than anticipated market demand. | Product Aminosyn II 10%, Sulfite-free; 1 L bag (NDC 0409-4164-05): ample supply available. Product Aminosyn 10%, Sulfite-free; 500 mL bag (NDC 0409-4191-03): ample supply available. Product Aminosyn 8.5%, Sulfite-free; 500 mL bag (NDC 0409-4187-03): next delivery March. Product Aminosyn 8.5%, Sulfite-free with Electrolytes, 500 mL (NDC 0409-4203-03): ample supply available. Product Aminosyn II 10%; 2 L bag (NDC 0409-7121-07): next delivery July. Product Aminosyn II 15%, Sulfite-free; 2 L bag (NDC 0409-7171-17): next delivery July. Product Aminosyn 10%, Sulfite-free, 1L (NDC 0409-4191-05): ample supply available. Product Aminosyn II 10%, 500 mL, Sulfite-free (NDC 0409-4164-03): ample supply available. Product Aminosyn HBC 7%, 500 mL, Sulfite-free (NDC 0409-4168-03): next delivery TBD. Please check with your wholesaler for available inventory. Other presentations available. Please see the Dear Customer Letter (PDF - 31KB) | Revised 3/15/2012 |
B. Braun Medical Inc. Customer Service: 1-800-227-2862 TrophAmine 6%, 500 mL (NDC 00264-9361-55) TrophAmine 10%, 500 mL (NDC 00264-9361-55) FreAmine III 10%, 1000 mL (NDC 00264-9010-55) Specialty Amino Acid Solutions FreAmine HBC 6.9%, 750 mL (NDC 00264-9350-55) NephrAmine 5.4%, 250 mL (NDC 00264-1909-55) HepatAmine 8%, 500 mL (NDC 00264-9371-55) | Available | All B. Braun Amino Acids are available. BBraun may start allocation if demand starts to exceed their increased production plans. | |
Baxter Customer Service: Travasol 10%, 500 mL (NDC 00338-0644-03) Prosol 20%, 2000 mL, sulfite-free (NDC 00338-0499-06) Clinisol 15%, 500 mL, sulfite-free (NDC 00338-0502-03) Premasol 6%, 500 mL, sulfite-free (NDC 00338-1131-03) Hepatosol 8%, 500 mL (NDC 00338-0504-03)
CLINIMIX E sulfite-free (2.75%, 4.25%, 5.0% Amino Acid with Electrolytes in Dextrose with Calcium) Injections in 1000 mL and 2000 mL Containers | Increase in product demand due to market supply issues. | Travasol products available Premasol products available Hepatosol product available Clinimix and Clinimix E products are available Baxter is currently experiencing a backorder situation on all presentations of Prosol and Clinisol due to unforeseen demand. Clinimix is a viable source of Amino Acids for most patients requiring parenteral nutrition. | Reverified 3/2/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 5 mEq/mL; 20 mL vial (NDC 0409-6043-01) | Other manufacturer shortages/market withdrawal. | Product 5 mEq/mL; 20 mL vial (NDC 0409-6043-01): company estimates a release date by June 2012. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (9/18/2008)
Company/Products | Reason | Related Information |
---|---|---|
Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week. | See information in Related Information section. | Limited supplies continue to be available. Please see attached Dear Healthcare Professional Letter (PDF - 66KB) for important safety information. |
Amphetamine Mixed Salts, ER Capsules (updated 10/31/2011)
Company/Products | Reason | Related Information |
---|---|---|
Shire Customer Service: 1-800-828-2088 Adderall XR capsules | API supply issues and uneven product distribution patterns. | Product availability for all dosage strengths is adequate. |
Teva Customer Service (888)838-2872 5 mg - 100 count (NDC 00555-0790-02); 10 mg - 100 count (NDC 00555-0787-02); 15 mg - 100 count (NDC 00555-0791-02); 20 mg - 100 count (NDC 00555-0788-02); 25 mg - 100 count (NDC 00555-0792-02); 30 mg - 100 count (NDC 00555-0789-02) | API supply issues | Teva continue to release product as it becomes available. |
Global Customer Service: (215)558-4300 10 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01) | Inadequate finished product supply to support current market demand | All finished product strengths are currently available on an allocated basis. |
Amphetamine Mixed Salts Immediate-Release Tablets (updated 1/12/2012)
Company/Products | Reason | Related Information |
---|---|---|
Sandoz Customer Service: 1-609-627-8500 5 mg tablets, 100 count (NDC 00185-0084-01) 10 mg tablets, 100 count (NDC 00185-0111-01) 20 mg tablets, 100 count (NDC 00185-0401-01) 30 mg tablets, 100 count (NDC 00185-0404-01) | Increase in demand | Releasing product as it becomes available. |
CorePharma 1-800-850-2719 5 mg tablets, 100 count (NDC 64720-0130-10) 10 mg tablets, 100 count (NDC 64720-0132-10) 20 mg tablets, 100 count (NDC 64720-0135-10) 30 mg tablets, 100 count (NDC 64720-0136-10) | Increase in demand | CorePharma is releasing product as it becomes available. |
Teva Customer Service: 1-888-838-2872 5 mg tablets, 100 count (NDC 00555-0971-02) 7.5 mg tablets, 100 count (NDC 00555-0775-02) 10 mg tablets, 100 count (NDC 00555-0972-02) 12.5 mg tablets, 100 count (NDC 00555-0776-02) 15 mg tablets, 100 count (NDC 00555-0777-02) 20 mg tablets, 100 count (NDC 00555-0973-02) 30 mg tablets, 100 count (NDC 00555-0974-02) Adderall, 5 mg tablets, 100 count (NDC 00555-0762-02) 7.5 mg tablets, 100 count (NDC 00555-0763-02) 10 mg tablets, 100 count (NDC 00555-0764-02) 12.5 mg tablets, 100 count (NDC 00555-0765-02) 15 mg tablets, 100 count (NDC 00555-0766-02) 20 mg tablets, 100 count (NDC 00555-0767-02) 30 mg tablets, 100 count (NDC 00555-0768-02) | API supply issues | Teva continue to release product as it becomes available. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. 1-877-946-7747 50,000 units/mL, 2 mL ampule (NDC 61703-418-07) | Change in manufacturing sites. | Hospira anticipates next delivery in December, 2012. | Revised 3/15/2012 |
Atracurium besylate (updated 2/27/2012)
Company/Products | Reason | Related Information |
---|---|---|
Bedford Customer Service: 1-800-562-4797 10 mg/mL, 5 mL vial, single dose vial (NDC 55390-0102-05) 10 mL vial, multi-dose vial (NDC 55390-0103-10) 5 mL Novaplus vial, single dose vial (NDC 55390-0180-05) 10 mL Novaplus vial, multi-dose vial (NDC 55390-0179-10) | Manufacturing delays | Atracurium besylate is on back order with no estimated date of availability. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Amphastar Pharmaceuticals Inc. Customer Service: 1-800-423-4136 0.1 mg/mL, 10 mL, Luer-Jet Prefilled Syringe | No current shortage | N/A | |
Hospira, Inc. Customer Service: 1-877-946-7747 0.1 mg/mL; 10 mL Ansyr syringe 0.05 mg/mL; 5 mL Ansyr syringe 0.1 mg/mL; 5 mL Lifeshield syringe 0.1 mg/mL; 10 mL Lifeshield syringe | Manufacturing delay | Product 0.1 mg/mL; 10 mL Ansyr syringe (NDC 0409-1630-10): ample levels of inventory to support market demand. Product 0.05 mg/mL; 5 mL Ansyr syringe (NDC 0409-9630-05): next delivery April. Product 0.1 mg/mL; 5 mL Lifeshield syringe (NDC 0409-4910-34): currently product is available. Product 0.1 mg/mL; 10 mL Lifeshield syringe (NDC 0409-4911-34): currently product is available. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
American Regent/Luitpold 1-800-645-1706 0.4 mg/mL, 0.5 mL ampule, package of 25 0.4 mg/mL, 1 mL single-dose vial, package of 25 1 mg/mL, 1 mL single-dose vial, package of 25 1 mg/mL, 1 mL ampule, package of 25 (NDC 00517-0101-25) | No stock available | Discontinued ampoules. American Regent anticipates to have lots available end of April 2012. | Revised 3/19/2012 |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 (Formerly a Baxter Product) 0.4 mg/mL, 20 mL vial | Increase in product demand. | West-Ward is currently experiencing a backorder situation on the 0.4 mg/mL, 20 mL vial.
|
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Schering Corporation, a subsidiary of Merck & Co. Inc., 1-800-672-6372 0.6MG/5ML, 4 fl.oz (NDC: 0085-0942-05) | Technical Issue | Voluntary product recall conducted Jan 23, 2012. Product will be unavailable for an undetermined period of time. | 3/8/2012 |
Bupivacaine Hydrochloride Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 | Increased demand | APP has Sensorcaine (with & without Epinephrine) on intermittent back-order and the company is releasing product as it becomes available. | Revised 3/13/2012 |
Hospira, Inc.
0.25%; 30 mL amp 0.25%; 10 mL vial 0.25%; 30 mL vial 0.25%; 50 mL vial 0.5%; 10 mL vial 0.5%; 30 mL vial 0.75%; 30 mL vial 0.25% w/epi 1:200,000; 10 mL vial 0.25% w/epi 1:200,000; 30 mL vial 0.5% w/epi 1:200,000; 10 mL vial 0.5% w/epi 1:200,000; 50 mL vial
50 mg/20 mL Sterile pack amp (NDC 0409-4272-01) | Manufacturing delays | Product 0.25%; 30 mL amp (NDC 0409-1158-01): next delivery April. Product 0.25%; 10 mL vial (NDC 0409-1159-01): next delivery March. Product 0.25%; 30 mL vial (NDC 0409-1159-02): next delivery March. Product 0.25%; 50 mL vial (NDC 0409-1160-01): next delivery March. Product 0.5%; 10 mL vial (NDC 0409-1162-01): next delivery March. Product 0.5%; 30 mL vial (NDC 0409-1162-02): next delivery April. Product 0.5%; 50 mL vial (NDC 0409-1163-01): next delivery March. Product 0.75%; 10 mL vial (NDC 0409-1165-01): next delivery March. Product 0.75%; 30 mL vial (NDC 0409-1165-02): next delivery March. Products 0.75% w/ dextrose 8.25%; 2 mL ampule (NDC 0409-3613-01): next delivery March. Product 0.25% w/epi 1:200,000; 10 mL vial (NDC 0409-9042-01): next delivery May. Product 0.25% w/epi 1:200,000; 30 mL vial (NDC 0409-9042-17): next delivery April. Product 0.25% w/epi 1:200,000; 50 mL vial (NDC 0409-9043-01): next delivery April. Product 0.5% w/epi 1:200,000; 10 mL vial (NDC 0409-9045-01): next delivery April. Product 0.5% w/epi 1:200,000; 30 mL vial (NDC 0409-9045-17): next delivery April. Product 0.5% w/epi 1:200,000; 50 mL vial (NDC 0409-9046-01): next delivery April. Product 50 mg/20 mL Sterile pack amp (NDC 0409-4272-01) next delivery March. Product 0.25%; 20 mL amp (NDC 0409-5622-01): next delivery March. Product 0.5%; 20 mL Sterile pack amp (NDC 0409-4273-01): next delivery March. Please check with your wholesaler for available inventory. | Revised 3/15/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Bedford 1-800-562-4797 1 mL vial (NDC 55390-0010-10) | Delays | Bedford has buprenorphine injection on back order and the company cannot estimate a release date. | |
Hospira 1-877-946-7747 1 mL Carpuject syringe (NDC 00409-2012-32 | Product modification | Hospira anticipates next delivery in September, 2012. | Reverified 3/16/2012 |
American Regent/Luitpold 1-800-645-1706 1 mL vial (NDC 00517-0725-05) | Delays | American Regent has buprenorphine injection 0.3 mg/mL 1 mL vials on back order and the company cannot estimate a release date. | Reverified 3/19/2012 |
Reckitt Benckiser 804-379-1090 Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01) | Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01) are available | Reckitt Benckiser has Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01) available. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc.
1 mg/mL; 1 mL vial (NDC 0409-1623-01)
(NDC 0409-1626-01)
(NDC 0409-1626-02) | Other manufacturer shortage/market withdrawal. | Product 1 mg/mL; 1 mL vial (NDC 0409-1623-01): next delivery April. Product 2 mg/mL; 1 mL vial (NDC 0409-1626-01): next delivery March. Product 2 mg/mL; 2 mL vial (NDC 0409-1626-02: next delivery April. Please check with your wholesaler for all available inventory. | Reverified 3/16/2012 |
Bedford Customer Service: 1-800-562-4797 1 mg/mL 1 mL vial (NDC 55390-0183-01) | Manufacturing delays | Bedford has all butorphanol presentations on back order and the company cannot estimate a release date. |
Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL)
Company/Products | Reason | Related Information | Related Information |
---|---|---|---|
American Regent/Luitpold: 631-924-4000 2 mL single-dose vial, package of 10 (NDC 00517-2502-10) | Manufacturing delays | American Regent has caffeine and sodium benzoate injection on back order and the company cannot estimate a release date. | Reverified 3/19/2012 |
Caffeine and Ergotamine Tartrate Tablet (Initial Posting-3/8/2012)
Company/Products | Reason | Related Information | Related Information |
---|---|---|---|
Sandoz Customer Service: 1-609-627-8500 100 mg caffeine/ 1 mg ergotamine tartrate; 100 count bottle (NDC 00781-5405-01 | Change in the raw material plant location | Temporarily unavailable and Sandoz cannot estimate a release date. We will continue to provide updates as further information becomes available | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent/Luitpold 1-800-645-1706 1 mcg/mL; 1 mL ampule, 25 count (NDC 00517-0132-25) | Available | American Regent, Inc. is currently releasing Calcitriol Injection 1 mcg/mL in a 1 mL ampoule as they become available. | Revised 3/19/2012 |
APP Pharmaceuticals 1-888-386-1300 1 mcg/ml; 1 mL ampule, 50 count (NDC 63323-0731-01 | Available | APP has Calcitriol injection available. | |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 1 mL ampule, 5 count (NDC 00143-9728-05) | Contract manufacturer cannot meet USP requirements | West-Ward has calcitriol injection on back order and the company cannot estimate a release date. | |
Akorn Pharmaceuticals 1-800-932-5676 Akorn 1 mL ampule, 10-pack (NDC 17478-0931-01) | n/a | Wholesalers have product. Product releases scheduled for March and April to support market demand. | Revised 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc.
100 mg/mL; 10 mL Abboject (NDC 0409-4928-34)
100 mg/mL; 10 mL Ansyr (NDC 0409-1631-10) | Manufacturing delay | Product 100 mg/mL; 10 mL Abboject (NDC 0409-4928-34): next delivery March.
Product 100 mg/mL; 10 mL Ansyr (NDC 0409-1631-10): next delivery March.
Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
American Regent/Luitpold 1-800-645-1706 10%, 10 mL vial | Available | American Regent, Inc. is currently releasing Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial. | Reverified 3/19/2012 |
Amphastar Pharmaceuticals, Inc./IMS 1--800-423-4136 | Amphastar (IMS) in cooperation with FDA will re-introduce its emergency syringes including Dextrose 50%, Epinephrine 0.1mg/mL, Calcium Chloride 100mg/mL, Sodium Bicarbonate 8.4%, Atropine Sulfate 0.1mg/mL, Lidocaine 2%, and Morphine 1mg/mL. Calcium Chloride 100mg/ml syringes (NDC 0548-3304-00/product code 3304) were released by Amphastar/IMS on 9/7/10 and are now available. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service 1-877-946-7747 4 mcg/mL; 10 mL vial | Other manufacturer shortage/market withdrawal. | Product 4 mcg/mL; 10 mL vial (NDC 0409-4093-01): next delivery April. | Reverified 3/16/2012 |
American Regent/Luitpold 1-800-645-1706 SOL 4 mcg/ml INTRAVENOUS 10 ml 25s (NDC 00517-6310-25) | Manufacturing delays | American Regent product is on back order with no estimated date of availability. | Reverified 3/19/2012 |
Cisplatin injection 1 mg/mL solution
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 1 mg/ml; 50 mL vial (NDC 63323-0103-51) 1 mg/ml; 100 mL vial (NDC 63323-0103-65) 1 mg/ml; 200 mL vial (NDC 63323-0103-64) | Increased Demand | APP is allocating 1 mg/ml; 50 mL vial (NDC 63323-0103-51), 1 mg/ml; 100 mL vial (NDC 63323-0103-65), & 1 mg/ml; 200 mL vial (NDC 63323-0103-64) – check wholesalers for inventory. | Revised 3/12/2012 |
Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva continues to release cisplatin injection 1 mg/mL solution. 50 mL vial (NDC 00703-5747-11) and 100 mL vial (NDC 00703-5748-11) as it becomes available. | Reverified 3/15/2012 |
Bedford 1-800-562-4797 | Product discontinued | Bedford currently has all presentations discontinued. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Ferring Pharmaceuticals, Inc. (973) 796-1600 EQ 0.1 MG Base/Vial (NDC 55566-0302-1) | Manufacturing | No stock available. | Reverified 3/16/2012 |
Daunorubicin Hydrochloride Solution for Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals 1-800-545-8800 5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13) | Manufacturing issues | Teva has daunorubicin 5 mg/ml 4ml vials (NDC 00703-5233-13) available but the company is reviewing orders prior to release and the product is available through drop shipment only. | Reverified 3/15/2012 |
Bedford Customer Service 5 mg/mL, 4 mL single-dose vial (NDC 55390-0108-10)
10 mL single-dose vial (NDC 55390-0108-01)
Cerubidine lyophilized powder for injection, 20 mg single-dose vial, package of 10 (NDC 55390-0281-10) | Manufacturing delays | Bedford Laboratories has limited quantities available of daunorubicin 5 mg/mL in 4 mL and 10 mL single-dose vials (NDC 55390-0108-10, and NDC 55390-0108-01), and 20 mg cerubidine lyophilized powder for injection (NDC 55390-0281-10)
The company cannot estimate a future release date for more product. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Ferring 1 888 Ferring (1-888-337-7464) 4 mcg/mL 1ml vials (NDC 55566-5030-01) and 4mcg/mL 10ml (NDC 55566-5040-01) | Manufacturing delay | Ferring currently has no inventory of the 10 mL vial available (NDC 55566-5040-01) The firm anticipates additional limited inventory of the ampoules in March 2012. | Revised 3/16/2012 |
Hospira Inc. Customer Service: 1-877-946-7747 4 mcg/mL, 1 mL amp (NDC 00409-2265-01) | Manufacturing delay | Product 4 mcg/mL; 1 mL amp (NDC 0409-2265-01): next delivery March 2012. Please check with your wholesaler for available inventory.
| Reverified 3/16/2012 |
Sanofi-Aventis 1-800-981-2491 (DDAVP) 4 mcg/mL; 1 mL ampule (NDC 00075-2451-01) | Available | Sanofi-Aventis desmopressin has both presentations available. | Reverified 3/16/2012 |
Teva Pharmaceuticals 1-800-545-8800 (4 mcg/mL, 1 mL vial, 10 count (NDC 00703-5051-03) 10 mL multi-dose vial (NDC 00703-5054-01)). | Manufacturing delays | Teva has all Desmopressin Injection on back order. The company estimates availability of product again in Q412. | Reverified 3/15/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Mylan Institutional 1-888-258-4199 Dexrazoxane for injection 250 mg vial (NDC 67457-0207-25) 500 mg vial (NDC 67457-208-50) | Increased demand | Expected release in mid 2012. | Reverified 3/15/2012 |
Pfizer Injectables 1-800-533-4535 | Pfizer has product available for both strengths. | Pfizer Injectables has available vials of 250 mg NDC (0013-8717-62), 500 mg (NDC 0013-8727-89). | |
Topotarget USA, Inc. 1-973-895-6900 Totect 500 mg (dexrazoxane) for injection | Manufacturing Delays | Limited supplies available at Cardinal, McKesson Specialty and Morris & Dickson each have 2 kits a piece (total 6 kits). Please check with these wholesalers directly for available inventory. Out of stock at ICS, ASD Healthcare, Oncology Supply and US Oncology. Topotarget USA, Inc. has product on back order and the company cannot estimate a release |
Dextroamphetamine Tablets (1/12/2012)
Company/Products | Reason | Related Information |
---|---|---|
Teva Pharmaceuticals 1-800-545-8800 5 mg tablets, 100 count (NDC 00555-0952-02) | Manufacturing delays | Teva has dextroamphetamine 5 mg and 10 mg, 100 count tablets, will be on intermittent back order through mid-2012. Product will be released as it becomes available. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 5 mg/mL; 2 mL Carpuject (0409-1273-32) 5 mg/mL; 10 mL vial | Manufacturing delay. | Product 5 mg/mL; 2 mL Carpuject (0409-1273-32): next delivery March. Product 5 mg/mL; 10 mL vial (0409-3213-12): next delivery April. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 (Formerly a Baxter Product) 250 mcg/mL, 2 mL ampuls (NDC 0641-1410-35) | Increase in product demand | West-Ward is currently experiencing a backorder situation on the 2 mL ampul.
Production has been accelerated and several additional lots are scheduled to be released by the end of March 2012.
Product will be made available as it is released. | Revised 3/12/2012 |
Sandoz Customer Service: 1-609-627-8500 USP 0.25 mg/mL, 2 mL (NDC 0781-3059-95) | Discontinued | Sandoz discontinued manufacturing in March, 2011. | Reverified 3/16/2012 |
Covis Pharma S.à.r.l Customer Service: Lanoxin Injection, USP 250 mcg/mL, 2 mL (10s - NDC 00173-0260-10)
| Manufacturing delays | Lanoxin Injection 250 mcg/mL, 2 mL (10s - NDC 00173-0260-10) is currently available in limited quantities through March 2012 with full availability expected in April 2012.
Covis Pharma S.à.r.l has discontinued manufacturing Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35). |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
West-Ward Pharmaceuticals Customer Service (Formerly a Baxter Product) 5 mL vial (NDC 10019-510-01) 10 mL vial (NDC 10019-510-02) 25 mL vial (NDC 10019-510-04) | Increase in product demand | West-Ward is experiencing a back order situation on all codes and estimates the following product availability: 5 mL vial (NDC 10019-510-01) Additional product releases expected later this month and at the end of May. 10 mL vial (NDC 10019-510-02) - Product will be available end of May 25 mL vial (NDC 10019-510-04) - Product releases expected by mid April and end of May. Product will be made available as it is released. | |
Hospira Customer Service (1-877-946-7747) 5 mg/mL, 5 mL vials (NDC 00409-1171-01)
5 mg/mL, 10 mL vials (NDC 00409-1171-02) 100 mg/mL, ADD-Vantage vials (NDC 00409-4350-03) | Other Manufacturer Shortages/Market Withdrawal
| Product 5 mg/mL; 5 mL vial (NDC 0409-1171-01): next delivery March. Product 100 mg/mL; ADD-Vantage vial (NDC 0409-4350-03): ample supply available. Product 5 mg/mL; 10 mL vial (NDC 0409-1171-02): next delivery March. Please check with your wholesaler for available inventory.
| Reverified 3/16/2012 |
Bedford Customer Service 1-800-562-4797 5 mg/mL 5 mL vials (NDC 55390-0565-05), 5 mg/mL 10 mL vials (NDC 55390-0565-10) 5 mg/mL 25 mL vials (NDC 55390-0565-30), 5 mg/mL 5 mL Novaplus vials (NDC 55390-0566-05) 5 mg/mL 10 mL Novaplus vials (NDC 55390-0566-10), 5 mg/mL 25 mL Novaplus vials (NDC 55390-0566-30) | Manufacturing delays | Bedford has all diltiazem presentations on back order and the company cannot estimate a release date. | |
Akorn Pharmaceuticals 1-800-932-5676 5 mg/mL, 25 mL vials (NDC 17478-0937-25) | N/A | All SKUs available by end of month. Increased production available, contingent on market demand. | Revised 3/16/2012 |
Diphenhydramine Hydrochloride Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 50 mg/ml, 1 ml (NDC 63323-0664-01) | Increased in demand | APP 50 mg/ml, 1 ml (NDC 63323-0664-01) is available. Please check wholesalers for inventory. | Revised 3/12/2012 |
Hospira Customer Service 1-877-946-7747 50 mg/mL; 1 mL Carpuject (NDC 0409-2290-31) | Manufacturing delays | Product 50 mg/mL; 1 mL Carpuject (NDC 0409-2290-31): next delivery June 2012. | Reverified 3/2/2012 |
Mylan Institutional 1-888-258-4199 50 mg/ml, 10 ml, 10s | Increased demand | Mylan has increased production in an effort to keep up with current demand. | Reverified 3/15/2012 |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 (Formerly a Baxter Product) 50 mg/mL, 1 mL vial | Increased demand | West-Ward is currently experiencing a backorder situation on the 50 mg/mL, 1 mL vial.
West-Ward has accelerated production on this product and is projecting availability of additional units by the end of March – beginning of April 2012.
Product will be made available as it is released. | Revised 3/15/2012 |
Doxorubicin (adriamycin) lyophilized powder (updated 12/2/2011)
Company/Products | Reason | Related Information |
---|---|---|
Bedford 10 mg vials (NDC 55390-0231-01) 20 mg vials (NDC 55390-0232-10) 50 mg vial (NDC 55390-0233-01) | Manufacturing delays | Bedford has all doxorubicin lyophilized presentations on back order and the company cannot estimate a release date. |
Doxorubicin Liposomal (Doxil) Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Janssen Products, LP (formerly Centocor Ortho Biotech Products, L.P.) 1-800-526-7736 (1-800-JANSSEN) Doxil 2 mg/mL, Janssen Products, LP | Manufacturing delays | Please see http://www.doxil.com/sites/default/files/DHCP_september2011.pdf for additional information. | |
Sun Pharma Global FZE (Caraco Pharmaceutical, U.S. distributor) 1-888-835-2237 | Sun Pharma Global FZE, and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd, in conjunction with the FDA, are initiating a temporary importation of Lipodox (doxorubicin HCL liposomal for injection), into the United States market to address this shortage. Please see the Dear Healthcare Professional Letter (PDF - 65KB) for information about supplies that are now available to help address the current shortage.
| 3/8/2012 |
Doxorubicin Solution for Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 APP Product Availability Information | Increased demand | APP has available the 2 mg/mL 5 mL vials (NDC 63323-883-05), the 2 mg/mL 10 mL vials (NDC 63323-883-10), the 2 mg/mL 25 mL vials (NDC 63323-0883-30), and the 2 mg/mL 100 mL vials (NDC 63323-0101-61). | |
Teva Pharmaceuticals
2 mg/mL; 5 mL vial (NDC 00703-5043-03) | Manufacturing delays | Teva has all doxorubicin injection on back order and the company estimates a release date of May 2012. | Reverified 3/12/2012 |
Bedford 1-800-562-4797 | Manufacturing delays | Bedford has all doxorubicin solution presentations on backorder and the company cannot estimate a release date. | |
Pfizer Injectables 1-800-533-4535 http://www.pfizerinjectables.com/ | Pfizer has product available | Pfizer Injectables has available vials of 10mg/5mL (NDC 0069-3030-20), 20mg/10mL (NDC 0069-3031-20), 50mg/25mL (NDC 0069-3032-20), 150mg/75mL (NDC 0069-3033-20), 200mg/100mL (NDC 0069-3034-20). |
Ethiodol (ETHIODIZED OIL) ampules
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Guerbet LLC Customer Service (1-877-729-6679) | Product has been discontinued by Nycomed US Inc. | Guerbet has acquired the Ethiodol NDA from Nycomed US Inc. effective May 7, 2010 and is working with FDA to resume manufacturing of Ethiodol in the near future to ensure continued availability for the US patients. During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ULTRA-FLUIDE, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. See Dear Healthcare Professional Letter (PDF - 483KB) for additional information. | Revised 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent/Luitpold 1-800-645-1706 2 mg/mL vial 20 mL vial (NDC 00517-0781-10) | Increase demand | American Regent anticipates to have product available end of March 2012. | Revised 3/19/2012 |
Hospira Inc. Customer Service 1-877-946-7747 2 mg/mL; 10 mL vial (NDC 0409-6695-01) 2 mg/mL; 20 mL vial (NDC 0409-6695-02) 2 mg/mL; 20 mL Abboject syringe (NDC 0409-8060-29) 2 mg/mL; 20 mL amp (NDC 0409-8061-01) 2 mg/mL; 10 mL amp (NDC 0409-8062-01) | Manufacturing Delay | Product 2 mg/mL; 10 mL vial (NDC 0409-6695-01): next delivery June. Product 2 mg/mL; 20 mL vial (NDC 0409-6695-02): next delivery June. Product 2 mg/mL; 20 mL Abboject syringe (NDC 0409-8060-29): next delivery June. Product 2 mg/mL; 20 mL amp (NDC 0409-8061-01): next delivery June. Product 2 mg/mL; 10 mL amp (NDC 0409-8062-01): next delivery June. | Reverified 3/15/2012 |
Bedford Customer Service: 1-800-562-4797 2 mg/mL injection 20 mL | Manufacturing Delay | Etomidate injection is on back order with no estimated date of availability. | |
Pfizer Customer Service: Pfizer Injectables 1-800-533-4535 20 mg/10ml injection (NDC 0069-0006-01) 40 mg/20ml injection (NDC 0069-0006-03) | Available | Pfizer's etomidate injection, 20 mg/10ml injection (NDC 0069-0006-01) and 40mg/20ml injection (NDC 0069-0006-03) will be available by last week of March, 2012. |
Etoposide solution for injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Bedford 1-800-562-4797 | Increased demand | Bedford has all etoposide presentations on back order and the company cannot estimate a release date. | |
Teva Pharmaceuticals
Toposar | Manufacturing delays | Teva has all Etoposide solution for injection available. | Revised 3/15/2012 |
APP
| Increased demand | APP is allocating all etoposide 20 mg/mL 5 mL and 25 mL vials & 50 mL vials. | Revised 3/12/2012 |
BMS Customer Service 1-800-426-7644 | Increased demand | BMS has available Etopophos 100 mg powder for injection (NDC 00015-3404-20). | |
Accord Healthcare 919-941-7879 100mg/5mL, 5mL vial (NDC#16729-114-31) | Increase in demand | Accord anticipates product will be avialable in early March and will be releasing product as it becomes available. | Revised 3/1/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 0.05 mg/mL; 2 mL Carpuject 0.05 mg/mL; 2 mL amp 0.05 mg/mL; 5 mL amp 0.05 mg/mL; 20 mL amp 0.05 mg/mL; 2 mL vial 0.05 mg/mL; 5 mL vial 0.05 mg/mL; 10 mL vial 0.05 mg/mL; 20 mL vial 0.05 mg/mL; 50 mL vial | Manufacturing delay | Product 0.05 mg/mL; 2 mL amp (0409-9093-32): next anticipated delivery April. Product 0.05 mg/mL; 5 mL amp (0409-9093-35): next anticipated delivery March. Product 0.05 mg/mL; 20 mL amp (0409-9093-38): next anticipated delivery March. Product 0.05 mg/mL; 2 mL vial (0409-9094-22): next anticipated delivery May. Product 0.05 mg/mL; 5 mL vial (0409-9094-25): next anticipated delivery May. Product 0.05 mg/mL; 10 mL vial (0409-9094-28): next anticipated delivery May. Product 0.05 mg/mL; 20 mL vial (0409-9094-31): next anticipated delivery May. Product 0.05 mg/mL; 50 mL vial (0409-9094-61): next anticipated delivery May. Fentanyl products listed above must be ordered through the wholesaler; check with your wholesaler regarding product allocation. It is recommended that the user institute fentanyl sparing strategies. Product 0.05 mg/mL; 2 mL Carpuject (0409-1276-32): next delivery March. Carpuject orders (NDC 0409-1276-32) may be placed direct or through the wholesaler, and will be filled in the order in which received. | Reverified 3/16/2012 |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 (Formerly a Baxter Product) 50 mcg/mL 2 mL ampul 5 mL ampul 20 mL ampul 2 mL vial 5 mL vial 20 mL vial 50 mL vial | Increase in product demand due to market supply issues. | West-Ward is currently experiencing a backorder situation on most presentations due to market demand. There are limited quantities currently available of the 5 mL and 20 mL vials.
West-Ward has accelerated production on all codes and will have the following products available:
Lots of the 2 mL, 5 mL, 20 mL, and 50 mL vials are scheduled to be manufactured and available for release in the March - April 2012 timeframe.
Product will be made available as it is released. | Revised 3/13/2012 |
Akorn Pharmaceuticals 1-800-932-5676 2 mL (NDC 1748-0030-02) 5 mL (NDC 1748-0030-05) 20 mL (NDC 1748-0030-20) | N/A | 2 mL and 5 mL releasing in March. 20 mL releasing early April. Increased production available, contingent on market demand. | Revised 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Mylan Institutional 1-888-258-4199 | Increased demand | Mylan Institutional (formerly Bioniche Pharma) has fluorouracil injection 50 mg/mL vials on intermittent back order and the company is releasing allocated product as it becomes available. It is only available for drop shipment orders through wholesalers at this time. | Reverified 3/15/2012 |
Teva Pharmaceuticals
50 mg/mL; 10 mL vial (NDC 00703-3015-13) | Manufacturing delays | Teva has fluorouracil injection 50 mg/mL in 10 mL, 50 mL and 100 mL vials available with ample inventory. | Reverified 3/15/2012 |
APP
50 mg/ml; 10 mL vial (NDC 63323-0117-10) | Increased demand | APP has all presentations of Fluorouracil available. Check with wholesalers for inventory. | Revised 3/12/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service 1-877-946-7747 24 mg/mL; 250 mL bottle 24 mg/mL; 500 mL bottle | Production temporarily suspended | Hospira has partnered with Clinigen to distribute UK product. See Clinigen posting below with Dear Healthcare Professional Letter for details. | Revised 3/16/2012 |
Clinigen Healthcare | Please see attached Dear Healthcare Professional Letter (PDF - 519KB) for updated information regarding distribution. |
Helidac (bismuth subsalicylate/tetracycline hydrochloride/metronidazole) Therapy (Initial Posting - 3/8/2012)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Prometheus Laboratories Inc. 1-888-423-5227 option 3 HELIDAC (bismuth subsalicylate/tetracycline hydrochloride/metronidazole) Therapy (NDC 65483-495-14) | Material Shortage (Tetracycline HCl capsules) | Prometheus has limited product available and cannot estimate a release date for new batches. |
Hydromorphone Hydrochloride Injection (Initial Posting-3/7/12)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 | Material Shortage | Product 1 mg/mL; 1 mL amp (NDC 0409-2552-01): next delivery March. Product 1 mg/mL; 1 mL Carpuject (NDC 0409-1283-31): next delivery March. Product 1 mg/mL; 1 mL iSecure (NDC 0409-1283-10): next delivery April. Product 2 mg/mL; 1 mL vial (NDC 0409-3365-01): next delivery March. Product 2 mg/mL; 1 mL amp (NDC 0409-3356-01): next delivery April. Product 2 mg/mL; 1 mL iSecure (NDC 0409-1312-10): next delivery April. Product 10 mg/mL; 5 mL vial (NDC 0409-2634-05): next delivery May. Product 10 mg/mL; 50 mL vial (NDC 0409-2634-50): ample supply available. Please check with your wholesaler for available inventory. | Revised 3/15/2012 |
Teva Pharmaceuticals 1-800-545-8800 10 mg/mL, 1 mL vials (NDC 00703-0110-03) 10 mg/mL, 5 mL vials (NDC 00703-0113-03) 10 mg/mL, 50 mL vials (NDC 00703-0118-01) | Available | Product available | Reverified 3/15/2012 |
West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 2 mg/mL, 1 mL vials (NDC 00641-0121-25) 2 mg/mL, 20 mL multi-dose vials (NDC 00641-2341-41) | Increase in product demand. | West-Ward is currently experiencing a backorder situation on both presentations.
West-Ward has increased production and is anticipating having several lots of the 1 mL vial released and available by the end of March 2012. Additional lots are scheduled for production in the April – May 2012 timeframe.
Several lots of the 20 mL vial will also be available by the middle of April 2012.
Product will be made available as it is released. | Revised 3/15/2012 |
Akorn Pharmaceuticals 10 mg/mL, 1 mL ampules (NDC 17478-0540-01)
| Information pending | 1 mL ampoule (NDC 17478-0540-01)-Readily available 5 mL ampoule (NDC 17478-0540-05)-Releasing mid-April 50 mL vial (NDC 17478-0540-50)-Readily available | Revised 3/16/2012 |
Purdue 1 mg/mL, 1 mL ampules, package of 10 (NDC 59011-0441-10) 2 mg/mL, 1 mL ampules, package of 10 (NDC 59011-0442-10) Dilaudid-HP injection | Manufacturing shortage | The only product with a shortage is the 2mg/ml, package of 25 (NDC 59011-0442-25). All other products are available. | Revised 3/12/2012 |
Insulin glulisine [rDNA origin] injection) solution for injection (Apidra SoloStar)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Sanofi-Aventis 1-800-981-2491 | Manufacturing delays | Product to be available 2nd quarter 2012. Please note Apidra vials are not impacted by this shortage. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 Liposyn III (fatemulsion/soybean oil) 10%; 250 mL (NDC 0409-9790-02) 10%; 500 mL (NDC 0409-9790-03) 20%; 250 mL (NDC 0409-9791-02) 20%; 500 mL (NDC 0409-9791-03) 30%; 500 mL (NDC 0409-6892-03) | Manufacturing delay | Products 10%; 250 mL (NDC 0409-9790-02), 10%; 500 mL (NDC 0409-9790-03), 20%; 250 mL (NDC 00409-9791-02), 20%; 500 mL (NDC 00409-9791-03) and 30%; 500 mL (NDC 00409-6892-03): Hospira is working with FDA to address the issues. | Reverified 3/16/2012 |
Baxter (Intralipid Emulsion) Customer Service: (1-888-229-0001) | Baxter now has adequate supply available to meet demand. | Baxter has the following Intralipid emulsions available through normal distribution: 20% 100 mL (NDC 00338-0519-48) 20% 250 mL (NDC 00338-0519-02) 20% 500 mL (NDC 00338-0519-03) 20% 1000 mL (NDC 00338-0519-04) 30% 500 mL (NDC 00338-0520-03) | Reverified 3/2/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Customer Service: (888)838-2872 (300 mg - 30s - 00555-0071-01, 100s - 00555-0071-02, 1000s - 00555-0071-05; 100mg - 100s - 00555-0066-02, 1000s - 00555-0066-05) | Delayed release | Releases planned for September for 300 mg product, 100 mg product continues to be in supply. | |
Sandoz Customer Service: 1-609-627-8500 (300 mg - 30s - 00185-4350-30, 100s - 00185-4350-01, 1000s - 00185-4350-10; 100mg - 30s - 00185-4351-30, 100s - 00185-4351-01, 1000s - 00185-4351-10) | API supply issues | 100 mg product currently available 300 mg product available around july 2012 | Reverified 3/16/2012 |
VersaPharm Service: 1-800-548-0700 (300 mg - 30s - 61748-0013-30, 100s - 61748-0013-01, 1000s - 61748-0013-10; 100mg - 100s - 61748-0016-01) | Information pending |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Bedford Customer Service 15 mg/mL 1 mL vial, 10 count (NDC 55390-0480-01)
30 mg/mL 1 mL vial, 10 count (NDC 55390-0481-01)
30 mg/mL 10 mL vial, 10 count (NDC 55390-0481-10) | Manufacturing delays | Bedford has all presentations of ketorolac injection on back order and the company cannot estimate a release date | |
American Regent/Luitpold 1-800-645-1706 15 mg/mL 1 mL vial, 25 count (NDC 00517-0601-25) 30 mg/mL 1 mL vial, 25 count (NDC 00517-0801-25) 30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00517-0902-25) | Unavailable | American Regent/Luitpold is currently not manufacturing Ketorolac Tromethamine Injection, USP | Reverified 3/19/2012 |
Wockhardt 30 mg/mL 1 mL vial, 10 count (NDC 64679-0758-04)
30 mg/mL 2 mL vial, 10 count (NDC 64679-0758-06)
30 mg/mL 2 mL vial, 25 count (NDC 64679-0758-02) | Increase in demand | Wockhardt has ketorolac 30 mg/mL 2 mL vials in 10 count and 25 count presentations on back order with an estimated release date of mid-late March, 2012. The 30 mg/mL 1 mL vial 10 count presentation is on back order and the company cannot estimate a release date. | Revised 3/9/2012 |
APP
15 mg/mL 1 mL vial, 25 count (NDC 63323-0161-01)
30 mg/mL 1 mL vial, 25 count (NDC 63323-0162-01)
30 mg/mL 2 mL vial for intramuscular injection, 25 count (NDC 63323-0162-02) | Raw material supply | APP has all presentations of ketorolac injection on back order and the company cannot estimate a release date. | Reverified 3/12/2012 |
Hospira, Inc. 15 mg/mL; 1 mL vial 15 mg/mL; 1 mL Carpuject 30 mg/mL; 1mL vial 30 mg/mL; 1 mL Carpuject 30 mg/mL; 2 mL Carpuject 60 mg/mL; 2 ml vial | Higher than anticipated market demand; Manufacturing delay. | Product 15 mg/mL; 1 mL vial (NDC 0409-3793-01): next delivery April. Product 30 mg/mL; 1mL vial (NDC 0409-3795-01): next delivery March. | Reverified 3/16/2012 |
Leucovorin Calcium Lyophilized Powder for Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Bedford Laboratories Customer Service 1-800-562-4797 | Manufacturing delays | Bedford has all leucovirin presenations on backorder and the company cannot estimate a release date. | |
Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva, in conjunction with the FDA, is initiating a temporary importation of Leucovorin Calcium Folinate Solution for Injection, to the United States market to address the current shortage. See Dear Healthcare Professional letter (PDF 692KB) for additional information. Teva is currently on backorder and anticipates limited resupply by end of April 2012. | Reverified 3/15/2012 |
APP Pharmaceuticals 1-888-386-1300 | Increased demand | APP is currently back-ordered due to increased demand. Intermittent releases are being allocated. (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV). | Revised 3/12/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva 1-800-545-8800 1 mg/0.2 ml (NDC 00703-4014-18) | Manufacturing delays | Currently on backorder, anticipate release is Q411. | Reverified 3/15/2012 |
Sandoz 1-609-627-8500 1 mg/0.2 ml (NDC 00185-7400-85) | Manufacturing site availability | Product currently unavailable. We will continue to provide updates as further information becomes available. | Reverified 3/16/2012 |
Caraco 313-871-8400 1 mg/0.2 ml (NDC 41616-0936-40) | Increase in demand | On intermittent backorder. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Akorn Pharmaceuticals 1-800-932-5676 25 mg/mL, 20 mL vial (NDC 17478-0107-20) 25 mg/mL, 30 mL vial (NDC 17478-0107-30) | Increased Demand | 20 mL (NDC 17478-0107-20)-Readily available 30 mL (NDC 1748-0107-30)-Readily available | Revised 3/16/2012 |
Sagent pharmaceuticals, Inc. 1-866-625-1618 250 mg_50 mL Premix Bag NDC 25021-132-81 500 mg_100 mL Premix Bag NDC 25021-132-82 750 mg_150 mL Premix Bag NDC 25021-132-83 | N/A | Sagent has both presentations of the Levofloxacin Injection vials available.
Sagent has all 3 strengths for premix bags available for contracted customers only | Revised 3/16/2012 |
Sandoz Customer Service: 1-609-627-8500 250 mg in 50 mL Dextrose 5%, premix bag (NDC 00781-3341-09) 500 mg in 100 mL Dextrose 5%, premix bag (NDC 00781-3342-09) 750 mg in 150 mL Dextrose 5%, premix bag (NDC 00781-3343-09) | Manufacturing delays | Sandoz has all levofloxacin presentations on back order and releasing product as it becomes available. | Reverified 3/20/2012 |
Levoleucovorin (Fusilev) 50 mg single use vials (updated 7/7/2011)
Company/Products | Reason | Related Information |
---|---|---|
Spectrum Pharmaceuticals 1-877-387-4538 or 1-877-FUSILEV | Fusilev (levoleucovorin) for Injection 50 mg vials (NDC 68152-101-00) are available from Spectrum Pharmaceuticals in ample quantities. Based upon the current and anticipated inventory, Spectrum Pharmaceuticals is able to meet all present and future demand. Please call the Company directly at 1-877-387-4538 to obtain Fusilev which is now approved for CRC. Reminder: There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg). For more information visit: Spectrum Pharmaceuticals web site. |
Lidocaine Hydrochloride Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP Customer Service: 1-888-386-1300 Lidocaine 0.5% Xylocaine 0.5% - MPF injection, APP Lidocaine 1% Xylocaine 1% injection Xylocaine 1% - MPF injection Lidocaine 1.5% Lidocaine 2% Xylocaine 2% injection Xylocaine 2% - MPF injection | Manufacturing delay | APP has all lidocaine and Xylocaine presentations on intermittent back order and will be releasing product as it becomes available. | |
Hospira, Inc. Customer Service: 1-877-946-7747 0.5% w/EPI 1:200,000; 50 mL vial (NDC 0409-3177-01) 1% w/EPI 1:100,000; 50 mL vial (NDC 0409-3178-03) 1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-65) 2% w/EPI 1:100,000; 20 mL vial (NDC 0409-3182-01) 2% w/EPI 1:100,000; 30 mL vial (NDC 0409-3182-02) 2% w/EPI 1:100,000; 50 mL vial (NDC 0409-3182-03) .0.5%; 50 mL FT vial (NDC 0409-4275-01) 0.5%; 50 mL TT vial (NDC 0409-4278-01) 1%; 2 mL amp (NDC 0409-4713-32) 1%; 5 mL amp (NDC 0409-4713-02) 1%; 20 mL vial (NDC 0409-4276-01) 1%; 30 mL vial (NDC 0409-4279-02) 1%; 50 mL vial (NDC 0409-4276-02) 1%; 30 mL Sterile Pack vial (NDC 0409-4270-01) 2%; 2 mL amp(NDC 0409-4282-01) 2%; 10 mL amp (NDC 0409-4282-02) 2%; 5 mL vial (NDC 0409-2066-05) 2%; 20 mL vial (NDC 0409-4277-01) 2%; 50 mL vial (NDC 0409-4277-02) 4%; 5 mL amp (NDC 0409-4283-01) | Manufacturing delay | Product 0.5% w/EPI 1:200,000; 50 mL vial (NDC 0409-3177-01): ample supply available. Product 1% w/EPI 1:100,000; 50 mL vial (NDC 0409-3178-03): next delivery March. Product 1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-65): next delivery March. Product 2% w/EPI 1:100,000; 20 mL vial (NDC 0409-3182-01): ample supply available Product 2% w/EPI 1:100,000; 30 mL vial (NDC 0409-3182-02): next delivery March. Product 2% w/EPI 1:100,000; 50 mL vial (NDC 0409-3182-03): next delivery March. Product 0.5%; 50 mL FT vial (NDC 0409-4275-01): next delivery March. Product 0.5%; 50 mL TT vial (NDC 0409-4278-01): next delivery March. Product 1%; 2 mL amp (NDC 0409-4713-32): next delivery April. Product 1%; 5 mL amp (NDC 0409-4713-02): next delivery March. Product 1%; 20 mL vial (NDC 0409-4276-01): next delivery March. Product 1%; 30 mL vial (NDC 0409-4279-02): next delivery March. Product 1%; 50 mL vial (NDC 0409-4276-02): next delivery March. Product 1%; 30 mL Sterile Pack vial (NDC 0409-4270-01): next delivery March. Product 2%; 2 mL amp (NDC 0409-4282-01): next delivery May. Product 2%; 10 mL amp (NDC 0409-4282-02): next delivery April. Product 2%; 5 mL vial (NDC 0409-2066-05): next delivery April. Product 2%; 20 mL vial (NDC 0409-4277-01): next delivery March. Product 2%; 50 mL vial (NDC 0409-4277-02): next delivery March. Product 4%; 5 mL amp (NDC 0409-4283-01): next delivery April. 1.5%; 20 mL amp (NDC 0409-4776-01): next delivery May. 1.5 %; 20 mL Sterile Pack amp, preservative-free (NDC 0409-4056-01): next delivery March. Available presentations: Please check with your wholesaler for available inventory. | Revised 3/15/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
West-Ward Pharmaceuticals Customer Service:
Ativan (lorazepam) Injection 2 mg/mL, 1 mL vial 2 mg/mL, 10 mL vial, (NDC 60977-116-02) 4 mg/mL, 1 mL vial 4 mg/mL, 10 mL vial, (NDC 60977-113-02)
Lorazepam Injection, USP 2 mg/mL, 1 mL vial 2 mg/mL, 10 mL vial, (NDC 10019-102-10) 4 mg/mL, 1 mL vial 4 mg/mL, 10 mL vial, (NDC 10019-103-10) | Increase in product demand due to market supply issues. | West-Ward is currently experiencing a backorder situation on all Ativan and Lorazepam codes. Manufacturing has been increased to meet product demand. Multiple lots of all codes are projected to be released and available in the late March – April 2012 timeframe. Product will be made available as it is released. | Revised 3/19/2012 |
Bedford Laboratories Customer Service: 1-800-562-4797 2 mg/mL, 1 mL vial (NDC 55390-0168-10), 10 mL vial (NDC 55390-0170-10) | Not currrently marketed. | Product Discontinued: Bedford currently has all presentations discontinued. | |
Hospira Inc. Customer Service: 2 mg/mL; 1 mL vial
| Manufacturing delay | Product 2 mg/mL; 10 mL vial (NDC 0409-6780-02): next delivery May. Product 2 mg/mL; 1 mL Carpuject syringe (NDC 0409-1985-30): next delivery March. Product 4 mg/mL; 1 mL vial (NDC 0409-6779-02): next delivery in May. Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02): next delivery in May.
Please note that 4 mg/mL; 1 mL Carpuject syringe (NDC 0409-1539-31) is temporarily unavailable. | Reverified 3/16/2012 |
Akorn: 847-279-6100 | N/A | Akorn has Lorazepam injection 2 mg/mL, 1 mL vials on intermittent back order and are filling direct orders and shipping to wholesalers as product becomes available. | Revised 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 500 mg/mL, 2 mL vial (NDC 63323-0064-02), 500 mg/mL, 10 mL vial (NDC 63323-0064-10), 500 mg/mL, 20 mL vial (NDC 63323-0064-20), 500 mg/mL, 50 mL vial (NDC 63323-0064-50) | APP has magnesium sulfate injection on shortage due to increased demand for the product. | APP has all magnesium sulfate 500 mg/mL presentations on intermittent back order and the company is releasing the product as it becomes available. | |
American Regent/Luitpold 1-800-645-1706 500 mg/mL, 2 mL vial (NDC 00517-2602-25), 500 mg/mL, 10 mL vial (NDC 00517-2610-25), 500 mg/mL, 50 mL vial (NDC 00517-2650-25) | Manufacturing delays | American Regent has all magnesium sulfate 500 mg/mL presentations on back order and the company cannot estimate a release date. | Reverified 3/19/2012 |
Hospira, Inc. Customer Service 1-877-946-7747
50%; 20 mL vial (NDC 0409-2168-02)
50 %; 10 mL Ansyr syringe (NDC 0409-1754-10)
40 mg/mL-water; 50 mL bag (NDC 0409-6729-24)
40 mg/mL-water; 100 mL bag (NDC 0409-6729-23)
40 mg/mL-water; 500 mL bag (NDC 0409-6729-03)
40 mg/mL-water; 1000 mL bag (NDC 0409-6729-09)
10 mg/mL-dextrose; 100 mL bag (NDC 0409-6727-23)
80 mg/mL-water; 50 mL bag (NDC 0409-6730-13) | Manufacturing delay | Product 50 %; 20 mL vial (NDC 0409-2168-02): next delivery March. Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next delivery March. Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): next delivery March. Product 40 mg/mL-water; 100 mL bag (NDC 0409-6729-23): next delivery March. Product 40 mg/mL-water; 500 mL bag (NDC 0409-6729-03): next delivery March. Product 40 mg/mL-water; 1000 mL bag (NDC 0409-6729-09): next delivery April. Product 10 mg/mL-dextrose; 100 mL bag (NDC 0409-6727-23): next delivery March. Product 80 mg/mL-water; 50 mL bag (NDC 0409-6730-13): next delivery March. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP Customer Service: 1-888-386-1300 250 mg/mL, 50 mL vial, 25 count | Increase in product demand. | APP has increased production and will have intermittent releases of product. | |
B. Braun Medical Inc. Customer Service: 1-800-227-2862 20% Mannitol Injection USP | No shortage | B. Braun has increased manufacturing forecast due to an increase in demand. B. Braun has inventory of the 500 mL and 250 mL product available and is scheduled to have additional product available mid February 2012. | |
Hosprira, Inc. Customer Service 1-877-946-7747 25%; 50 mL vial 20%; 250 mL container 20%; 500 mL container | Manufacturing delay | Product 25%; 50 mL vial (NDC 0409-4031-01): next delivery April.
Product 20%; 250 mL container (NDC 0409-7715-02): next delivery 2012.
Product 20%; 500 mL container (NDC 0409-7715-03): next delivery 2012.
Please check with your wholesaler for all available inventory. | Reverified 3/2/2012 |
American Regent/Luitpold 1-800-645-1760 25%, 50 mL vial | Available | American Regent is releasing Mannitol injection as it becomes available. | Revised 3/19/2012 |
Baxter Customer Service: 1-800-ANA-DRUG (1-800-262-3784) 20% OSMITROL Injection (20% Mannitol Injection, USP). NDC: 0338-0357-02 20% OSMITROL Injection (20% Mannitol Injection, USP). NDC: 0338-0357-03 | Product Available | Reverified 3/2/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Sagent Pharmaceticals: 1-866-625-1618 10 mL vials, 1 count (NDC 25021-0201-10) 10 mL vials, 10 count (NDC 25021-0201-11) | Manufacturing delays | The 10mL 1 count is on backorder and the 10 count product is on allocation. | Reverified 3/16/2012 |
APP: 1-888-386-1300 10 mL vial, 1 count (NDC 63323-0773-11) 10 mL vial, 10 count (NDC 63323-0773-10) | Available | APP has available both 10 mL vials in the 1 count and 10 count. | Reverified 3/12/2012 |
Bedford: 1-800-562-4797 10 mL vial, 1 count (NDC 55390-0045-01) | Manufacturing delays | Bedford has mesna injection on back order and the company cannot estimate a release date. | |
Teva: 1-800-545-8800 10 mL vial, 10 count (NDC 00703-4805-03) | Manufacturing delays | Teva has limited inventory available on allocation. | Revised 3/15/2012 |
Baxter Customer Service: 1-800-ANA-DRUG (1-800-262-3784) Mesna 10 mL vial, 1 count (NDC 10019-0953-01) 10 mL vial, 10 count (NDC 10019-0953-02) Mesnex 100 mg/mL Injection, 10 mL vial, 10 count (NDC 00338-1305-03 | Available | Baxter has the following products available: Product: Mesna 10 mL vial, 1 count (NDC 10019-0953-01) and 10 mL vial, 10 count (NDC 10019-0953-02). Product: Mesnex 100 mg/mL Injection, 10 mL vial, 1 count (NDC 00338-1305-01) and 10 mL vial, 10 count (NDC 00338-1305-03. | Reverified 3/2/2012 |
Mylan Institutional
| N/A | Mylan anticipates product will be available in April 2012. | Revised 3/20/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP Customer Service 1-888-386-1300 25 mg/mL; 2 mL vial; 25 mg/mL; 10 mL vial; | Discontinuation of 2ml vials. Increased demand. | Product 25 mg/mL; 2 mL vial (NDC 63323-0123-02) discontinued. Product 25 mg/mL; 10 mL vial (NDC 63323-0123-10) available. | |
Bedford Customer Service 1-800-562-4797 25 mg/mL; 2 mL vial; Preservative Free Methotrexate lyophilized powder for injection | Bedford Laboratories has multiple products affected by the suspension of manufacturing at Ben Venuein mid-November 2011. Availability of all products, including those not manufactured at Ben Venue, is updated as information changes on the Bedford Laboratories website | Bedford Laboratories has limited quantities available of methotrexate preservative-free 1 gram lyophilized powder for injection (NDC 55390-0143-01). Other presentations will not be available until capacity permits. | |
Hospira, Inc. Customer Service 1-877-946-7747 25 mg/mL; 2 mL vial 25 mg/mL; 40 mL vial; | Other manufacturer shortage/withdrawal | Product 25 mg/mL; 2 mL vial (NDC 61703-350-38): next delivery March. Product 25 mg/mL; 40 mL vial (NDC 61703-408-41): Hospira is working closely with the FDA to expedite releases of product. Hospira is releasing direct customer orders. Hospira estimates the next delivery late March. | Revised 3/15/2012 |
Hospira, Inc. Customer Service 1-877-946-7747 | Other manufacturer shortage/withdrawal | Hospira Healthcare Corporation, Canada and its authorized distributor Hospira, Inc in conjunction with the FDA, are initiating a temporary importation of Canadian approved Methotrexate Injection, USP 1gm/40mL (25 mg/mL) (Preservative Free), into the U.S. market to address the shortage. Please see the Dear Healthcare Provider Letter (PDF - 353KB) for additional information. | 3/6/2012 |
Mylan Institutional 1-888-258-4199 25mg/ml; 2ml vial 25 mg/ml; 10ml vial 25 mg/ml; 40ml vial | Significant increase in demand. | Limited quantity of 2 ml vials (NDC 10139-0062-02) and 10 ml NDC 10139-0062-10) available for emergency drop ship orders. 40 ml vials (NDC 10139-0062-40) are planned to be available again in the coming weeks. As additional product becomes available, it will continue to be allocated via drop ship orders. | Revised 3/15/2012 |
Sandoz Customer Service: 1-609-627-8500 25mg/ml; 2ml vial 25mg/ml; 10ml vial 25mg/ml; 40ml vial | Manufacturing delays | Sandoz has temporarily discontinued 2ml (NDC 66758-0040-02) and 10ml (NDC 66758-0040-08) vials. Experiencing a back order on 40ml vials. | Reverified 3/20/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Sandoz Customer Service: 1-609-627-8500 5 mg (100s - NDC 00781-8840-01 & 00781-5748-01; 1000s - NDC 00781-8840-10), 10 mg (100s - NDC 00781-5749-01 & 00781-8841-01; 1000s - NDC 00781-1749-10), 20 mg (100s - NDC 00781-8842-01 & 00781-5753-01; 1000s - NDC 00781-1753-10) 20 mg (100s - NDC 00781-8843-01 & 00781-5754-01) | Capacity constraints and receiving API orders. | Expect sporadic backorders for the next couple of months. | Reverified 3/16/2012 |
Mallinckrodt Customer Service: (800) 325-8888 5 mg (100s - NDC 00406-1121-01; 1000s - NDC 00406-1121-10), 10 mg (100s - NDC 00406-1122-01; 1000s - NDC 00406-1122-10), 20 mg (100s - NDC 00406-1124-01; 1000s - NDC 00406-1124-10) Methylin ER, 10 mg (100s - NDC 00406-1423-01) and 20 mg (100s - NDC 00406-1451-01) | Continued recovery as a result of previously unavailable raw material | All strengths of methylphenidate IR and ER tablets will be increasingly available as supply recovery continues, with most contracted orders being met. | Reverified 3/16/2012 |
UCB Customer Service: 1-800-477-7877 5 mg (100s - NDC 53014-0531-07), 10 mg (100s - NDC 53014-0530-07), and 20 mg (100s - NDC 53014-0532-07) Metadate ER Tablets, 20 mg (100s - NDC 53014-0594-07) Metadate CD, 10 mg (100s - NDC 53014-0579-07), 20 mg (100s - NDC 53014-0580-07), 30 mg (100s - NDC 53014-0581-07), 40 mg (100s - NDC 53014-0582-07), 50 mg (100s - NDC 53014-0583-07), and 60 mg (100s - NDC 53014-0584-07) | Increased demand | UCB has availability of 5 mg IR tablets, 10 mg IR tablets and 20 mg ER tablets. UCB anticipates release of the 20 mg IR Tablets shortly. | Revised 3/8/2012 |
Watson Customer Service: (973) 355-8300 5 mg (100s - NDC 00591-5882-01), 10 mg (100s - NDC 00591-5883-01), and 20 mg (100s - NDC 00591-5884-01) | n/a | Watson has all 3 strengths available for contracted customers only. | |
Noven Customer Service: Daytrana (Methylphenidate Transdermal System)
15 mg (30s - NDC 68968-5553-3) 20 mg (30s - NDC 68968-5554-3) 30 mg (30s - NDC 68968-5555-3) | Not applicable | Currently all product is available |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent, Inc./Luitpold: 1-800-645-1706 50 mg/mL, 5 mL vial (NDC 00517-8905-10) | Manufacturing delays | American Regent has methyldopate injection on back order and cannot estimate a release date | Reverified 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 5 mg/mL 2 mL vials (NDC 00409-3414-01) | Manufacturing delay. | Product 5 mg/mL; 2 mL vial (NDC 0409-3414-01): next delivery March. Hospira discontinued Metoclopramide Carpuject syringes in May, 2009 and ampules in February, 2010. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Teva Pharmaceuticals 1-800-545-8800 5 mg/mL, 2 mL vial, 25 count (NDC 00703-4502-04) | Teva has made a business decision to discontinue this product. See the Dear Valued Customer Letter (PDF - 32KB) |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 1 mg/mL, 2 mL vial, 25 count (NDC 63323-0411-12) 1 mg/mL, 5 mL vial, 25 count (NDC 63323-0411-25) 1 mg/mL, 10 mL vial, 10 count (NDC 63323-0411-10) 5 mg/mL, 5 mL vial, 10 count (NDC 63323-0412-05) 5 mg/mL, 10 mL vial, 10 count (NDC 63323-0412-10) 5 mg/mL, 2 mL vial, 25 count (NDC 63323-0412-02) 5 mg/mL, 1 mL fill in 2 mL vial, 25 count (NDC 63323-0412-25) | Increased demand | APP has midazolam injection on intermittent back order and the company is releasing product on a regular basis. Check with wholesalers for inventory. | |
Bedford Customer Service: 1-800-562-4797 1 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0137-02) 1 mg/mL, 5 mL preservative-free vial, 10 count (NDC 55390-0137-05) 1 mg/mL, 10 mL vial, 10 count (NDC 55390-0125-10) 5 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0138-02) 5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01) 5 mg/mL, 5 mL vial, 10 count (NDC 55390-0126-05) 5 mg/mL, 10 mL vial, 10 count (NDC 55390-0126-10) | Temporary suspension of manufacturing. | Bedford has all midazolam presentations on back order and the company cannot estimate a release date.
The 1 mg/mL 2 mL and 10 mL vials and the 5 mg/mL 2 mL (1 mL fill), 5 mL and 10 mL vials vials are pending release while the other presentations will not be manufactured until capacity permits.
Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories manufactured products. Availability of products is updated on the Bedford Laboratories website | |
Hospira, Inc. Customer Service: 1-877-946-7747 1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 0409-2306-62) 1 mg/mL, 2 mL preservative-free vial (NDC 0409-2305-17) 1 mg/mL, 5 mL preservative-free vial (NDC 0409-2305-05) 1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 0409-2306-12) 1 mg/mL, 10 mL vial (NDC 0409-2587-05) 5 mg/mL, 1 mL preservative-free vial (NDC 0409-2308-01) 5 mg/mL, 5 mL vial (NDC 0409-2596-03) 5 mg/mL, 10 mL vial (NDC 0409-2596-05) 5 mg/mL, 1 mL preservative-free Luer-Lock syringe (NDC 0409-2307-60) 5 mg/mL, 2 mL preservative-free vial (NDC 0409-2308-02) | Other manufacturer shortage/withdrawal; Manufacturing delay; Quality improvement activities. | Product 1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 0409-2306-62): next delivery March. Product 1 mg/mL, 2 mL preservative-free vial (NDC 0409-2305-17): next delivery March. Product 1 mg/mL, 5 mL preservative-free vial (NDC 0409-2305-05): next delivery March. Product 1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 0409-2306-12): next delivery April. Product 1 mg/mL, 10 mL vial (NDC 0409-2587-05): next delivery March. Product 5 mg/mL, 1 mL preservative-free vial (NDC 0409-2308-01): next delivery March. Product 5 mg/mL, 5 mL vial(NDC 0409-2596-03): next delivery April. Product 5 mg/mL, 10 mL vial (NDC 0409-2596-05): next delivery March. Product 5 mg/mL, 1 mL preservative-free Luer-Lock syringe (NDC 0409-2307-60): next delivery 2013. Product 5 mg/mL, 2 mL preservative-free vial (NDC 0409-2308-02): next delivery April. Hospira discontinued the following products: | Reverified 3/16/2012 |
West-Ward (formerly Baxter products) Customer Service: (1-888-229-0001) 1 mg/mL, 2 mL vial, 10 count (NDC 10019-0028-02) 1 mg/mL, 2 mL dosette vial (NDC 10019-0028-03) 1 mg/mL, 5 mL vial, 10 count (NDC 10019-0028-05) 1 mg/mL, 10 mL vial, 10 count (NDC 10019-0028-10) 1 mg/mL, 2 mL vial, 25 count (NDC 10019-0028-04) 1 mg/mL, 2 mL latex free vial, 10 count (NDC 10019-0028-01) 5 mg/mL, 1 mL vial, 10 count (NDC 10019-0027-06) 5 mg/mL, 1 mL vial, 25 count (NDC 10019-0027-09) 5 mg/mL, 2 mL vial, 25 count (NDC 10019-0027-08) 5 mg/mL, 2 mL vial, 10 count (NDC 10019-0027-07) 5 mg/mL 10 mL vial, 10 count (NDC 10019-0027-10) | Increase in product demand | West-Ward is currently experiencing a backorder situation on the majority or Midazolam codes. Limited quantities are available of the 1 mg/mL and 5 mg/mL, 2 mL vials.
West-Ward has accelerated production and will have units of all presentations available for release in the March – April 2012 timeframe.
Additional lots are also projected to be manufactured in May 2012. | Revised 3/15/2012 |
Akorn: 847-279-6100 | N/A | All presentations- Re-launching late June. | Revised 3/16/2012 |
Sagent Pharmaceuticals, Inc. 1-866-625-1618 2 mg/2 mL vial (preservative-free), NDC 25021-655-02 5 mg/5 mL vial, (preservative-free) NDC 25021-655-05 5 mg/mL vial, (preservative-free) NDC 25021-656-01 10 mg/2 mL vial, (preservative-free) NDC 25021-656-02 10 mg/10 mL vial, NDC 25021-660-10 25 mg/5 mL vial, NDC 25021-661-05 50 mg/10 mL vial, NDC 25021-661-10 | Product Available | Sagent has all presentations of midazolam on allocation. | 3/26/2012 |
Mitomycin Powder for Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Accord Customer Service: 919-941-7879 5 mg (NDC 16729-0115-05) | Increase in demand | Accord currently has all presentations available and will continue releasing products as they become available. | Revised 3/1/2012 |
Bedford Laboratories: 1-800-562-4797 5 mg (NDC 55390-0251-01), 20 mg (NDC 55390-0252-01), 40 mg (NDC 55390-0253-01) | Manufacturing delays | Bedford has all mitomycin presentations on backorder and the company cannot estimate a release date. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc.
25 mg/mL, 10 mL Add-Vantage vial (NDC 0409-6179-14) | Manufacturing delay | Product 1 mg/mL, 30 mL PCA vial (NDC 0409-2029-02): Hospira is providing through direct customers only. Next delivery March. Product 5 mg/mL; 30 mL PCA vial (NDC 0409-6028-04): ample supply available. Product 2 mg/mL; 1 mL Carpuject (NDC 0409-1762-30): next delivery March. Product 4 mg/mL; 1 mL Carpuject (NDC 0409-1258-30): next delivery March. Product 8 mg/mL; 1 mL Carpuject (NDC 0409-1260-69): next delivery April. Product 10 mg/mL; 1 mL Carpuject (NDC 0409-1261-30): next delivery March. Product 15 mg/mL; 1 mL Carpuject syringes (NDC 0409-1264-31): next delivery August (prioritizing other more critical products first). Hospira has the following presentations of morphine injection available: | Revised 3/15/2012 |
Amphastar Pharmaceuticals Inc. Customer Service: 1-800-423-4136 Morphine Injection | No current shortage | Amphastar has the following available: 1 mg/mL, 10 mL Luer-lock syringes (NDC 00548-3391-00) | |
West-Ward Customer Service: 1-888-229-0001 Morphine injection 1 mL vial, 5 mg/mL 1 mL vial, 8 mg/mL 1 mL vial, 10 mg/mL) 10mL vial, 10 mg/mL 20 mL vial, 15 mg/mL | Increase in product demand | West-Ward has limited availability of the 15 mg/mL, 1 mL vial and 10 mg/mL in both 1 mL and 10 mL vials. All other presentations are on backorder. West-Ward has accelerated production on all morphine codes and is projecting to have multiple lots available by the end of March with additional units released in April 2012. Additional lots are also scheduled to be manufactured with an estimated availability in the May - June 2012 timeframe. Product will be made available as it is released. | Revised 3/16/2012 |
Morphine Sulfate Injection (Preservative Free)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 Astramorph (preservative-free) Inj 0.5 mg/mL 2 mL ampule, 10 count (NDC 63323-0291-80) 0.5 mg/mL 10 mL vial, 5 count (NDC 63323-0291-10) 1 mg/mL 2 mL ampule, 10 count (NDC 63323-0292-80) 1 mg/mL, 10 mL vial (NDC 63323-0292-10) | Change in manufacturing sites | APP has preservative-free Astramorph 0.5 mg/mL 2 mL ampules, 1 mg/mL 2 mL ampules and 10 mL ampules, and 0.5 mg/mL 10 mL vials on back order with an estimated release date in fourth quarter of 2012 | |
Hospira, Inc. Customer Service: 1-877-946-7747 0.5 mg/mL; 10 mL vial (NDC 0409-3814-12) 1 mg/mL; 10 mL vial (NDC 0409-3815-12) 25 mg/mL; 1 mL vial (NDC 0409-1135-02) | Manufacturing delay | Product 0.5 mg/mL; 10 mL vial (NDC 0409-3814-12): next delivery May. Product 1 mg/mL; 10 mL vial (NDC 0409-3815-12): next delivery March. Product 25 mg/mL; 1 mL vial (NDC 0409-1135-02): next delivery June | Revised 3/15/2012 |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 (Formerly a Baxter Product) Morphine injection West-Ward Pharmaceuticals Infumorph 20 mL ampul, 25 mg/mL (NDC 60977-115-01) Duramorph 10 mL ampul, 1 mg/mL) (NDC 60977-017-01) 10mL ampul, 0.5 mg/mL (NDC 60977-016-02) | Increase in product demand | West-Ward is currently experiencing a backorder situation on the Infumorph 25 mg/mL, 20 mL ampul and Duramorph 1 mg/mL, 10 mL ampul. Limited quantities of the other Infumorph and Duramorph codes are available. West-Ward has accelerated production on all preservative-free morphine codes and will have the following products available. Lots of both Infumorph codes are scheduled for production and will be available for release by the middle of May 2012. Several lots of Duramorph are scheduled for manufacturing at the end of March. Additional lots are projected to be manufactured and available in April 2012 | Revised 3/16/2012 |
Multi-Vitamin Infusion (Adult and pediatric)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira , Inc. Customer Service 1-877-946-7747 MVI-12 Adult; 10 mL vial (NDC 61703-423-81) | Production of Adult formulations temporarily suspended. | MVI Pediatric 5 mL vial (NDC 61703-421-53): ample levels of inventory to support market demand. | Reverified 3/16/2012 |
Baxter (Infuvite adult and pediatric IV solution)
INFUVITE Pediatric, Multiple Vitamins for Injection. Single Dose package. (NDC 54643-5646-1)
| Manufacturing delays | Baxter is the distributor of INFUVITE Multi Vitamins. Baxter has these multi-vitamin products on allocation and is working with the manufacturer to maximize the availability of INFUVITE Multi Vitamins.
| Reverified 3/2/2012 |
Mustargen (mechlorethamine HCl) injection (updated 1/6/2012)
Company/Products | Reason | Related Information |
---|---|---|
Lundbeck Inc. Customer service number: 1-888-514-5204 | See Related Information | Lundbeck has transferred production of Mustargen to a new manufacturing site and is in the process of securing supplies to reintroduce the product
Lundbeck expects Mustargen to be available again during second quarter 2012. Updates will be provided as they become available. Please see the Dear Healthcare Professional Letter (PDF - 24KB) from Lundbeck for additional information. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 Naloxone 0.4 mg/mL Injection (NDC 00409-1215-01 | Manufacturing delay | Product Naloxone 0.4 mg/mL Injection (NDC 00409-1215-01): next delivery April. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Mallinckrodt Customer Service: 1-800-325-8888 50 mg oral tablets | Raw material supply | Supply recovery continues, but may experience some backorders through April due to increased demand. | Revised 3/16/2012 |
Sandoz Customer Service: 1-609-627-8500 50 mg oral tablets, 100 count (NDC 00185-0039-01) | Supply issue | Product is discontinued at this time. | Reverified 3/16/2012 |
Teva Pharmaceuticals NALTREXONE HCL TABLETS 50MG 30, (NDC 00555-0902-01) NALTREXONE HCL TABLETS 50MG 100, (NDC 00555-0902-02) | Manufacturing Capacity | Product expected to be available as of 4/2/2012. | Revised 3/20/2012 |
NeoProfen (ibuprofen lysine) Injection (updated 12/15/2011)
Company/Products | Reason | Related Information |
---|---|---|
Lundbeck Inc. Customer service number: 1-888-514-5204 | Failure to meet a visible particulate quality specification. | Lundbeck voluntarily recalled NeoProfen as a safety precaution. As NeoProfen stock is being replenished by the manufacturer, supply is anticipated to be available in second quarter 2012. |
Neupro (rotigotine transdermal system) (5/5/2010)
Company/Products | Reason | Related Information |
---|---|---|
UCB, Inc 800-477-7877 | UCB has recalled all domestic lots | FDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation. If you have additional questions about the status of Neupro, or about UCB’s Patient Access program for Neupro, please contact UCB Medical Information at 1-866-822-0068 (option 9). |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 2 mL vials, package of 25 (NDC 63323-0373-02) | Increased demand | APP has Ondansetron 2 mg/mL 2 mL vials on back order with an estimated release date of late March 2012.
Limited quantities of the 20 mL multiple dose vials (NDC 63323-0374-20) are available. | |
Bedford 20 mL vial (NDC 55390-0121-01) 2 mL vials, packages of 10 (NDC 55390-0121-10) - discontinued | Temporary suspension of manufacturing. | Bedford has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate a release date. Bedford Laboratories has multiple products affected by this temporary suspension of manufacturing. Bedford will have the affected, as well as the available products, listed on their website and are updating this information as it changes. The company voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis for maintenance and requalification of equipment. Product will become available in stages as production resumes. Bedford discontinued the following products: | |
Apotex 2 mL vials, package of 5 (NDC 60505-0744-01) 20 mL multiple dose vial (NDC 60505-0744-06) | Apotex has discontinued the manufacturing of Ondansetron Injection. | Revised 3/2/2012 | |
Caraco 313-871-8400 2 mL ampules (NDC 62756-0181-01) 20 mL vials (NDC 62756-0182-01) | Caraco temporarily discontinued ondansetron injection | ||
Cura 2 mL vials, packages of 5 (NDC 46860-0087-06) | Pending information | Pending information | |
Hospira, Inc. Customer Service: 1-877-946-7747 2 mg/mL; 2 mL vials (NDC 0409-4755-03) 2 mg/mL; 20 mL vials (NDC 0409-4759-01) 0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24 | Other manufacturer shortage/withdrawal; Quality improvement activities. | Product 2 mg/mL; 2 mL vial (NDC 0409-4755-03): next delivery March. Product 2 mg/mL; 20 mL vial (NDC 0409-4759-01): next delivery March. Product 0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24): next delivery 2012. Product 2 mg/mL; 2 mL iSecure syringe (NDC 0409-1120-12): next delivery March. Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
West-Ward (formerly Baxter products) Customer Service: 2 mg/mL, 2 mL vial (NDC 0641-6078-25)
2 mg/mL, 20 mL Vial (0641-6079-01) | Increase in product demand. | West-Ward is currently experiencing a backorder situation on both the 2 mL and 20 mL vials.
West-Ward has accelerated production and is projecting to have additional units available.
Lots are scheduled for release in March and April 2012. | Revised 3/15/2012 |
Teva 1-800-545-8800 20 mL vials (NDC 00703-7226-01) 2 mL vials, packages of 5 (NDC 00703-7221-02) - discontinued | Teva discontinued ondansetron 2 mL vials in 5 count packages. Teva has the following presentation on intermittent back-order. These skus will remain on allocation through Q212: 2 mL vials, package of 25 (NDC 00703-7221-04) 20 mL vials, package of 10 (NDC 00703-7226-03) | Reverified 3/15/2012 | |
GlaxoSmithKline Customer Service: 1-888-825-5249 Zofran injection, 2 mg/mL, 20 mL vial | GlaxoSmithKline has the following available: 20 mL vial (NDC 00173-0442-00) GlaxoSmithKline has discontinued Zofran 2 mL vials | ||
Wockhardt 2 mL vials, package of 5 (NDC 64679-0726-01) 20 mL vials, package of 1 (NDC 64679-0727-01)) | Increased demand | Wockhardt has all presentations of Ondansetron 2 mg/mL on back order with an estimated release date of mid-late March 2012. | Revised 3/9/2012 |
Pfizer
Ondansetron 40mg/20mL x 1 MDV NDC 0069-1340-02 | Pfizer has the following presentations of ondansetron 2 mg/mL available in limited quantities: 2 mL vials, package of 25 (NDC 0069-1340-16) |
Ondansetron Injection 32 mg/50 mL premixed bags
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Claris 32 mg/50 mL (NDC 36000-0014-06) | Pending information | Pending information | |
Sagent Pharmaceuticals 1-866-625-1618 32 mg/50 mL (NDC 25021-0776-50) - discontinued | Discontinued | Sagent has discontinued their ondansetron premixed bags. | |
Teva Pharmaceuticals 1-800-545-8800 32 mg/50 mL (NDC 00703-7239-39) | Manufacturing delay | Teva has ondansetron 32 mg/50 mL premixed bags on back order and the company cannot estimate a release date. | Reverified 3/15/2012 |
Hospira, Inc. Customer Service: 1-877-946-7747 0.64 mg/mL; 50 mL bag | Other manufacturer shortage/withdrawal; Quality improvement activities. | Product 0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24): next delivery 2012. | Reverified 3/16/2012 |
West-Ward Pharmaceuticals Customer Service: (1-888-229-0001) 32 mg/50 mL | Pending information | Pending information | |
Baxter Customer Service: 1-888-229-0001 32 mg/50 mL (NDC 00338-1762-41) | Increase in demand | Baxter has 32 mg/50 mL premixed bags on back order with an estimated release date of late April 2012. | Revised 3/12/2012 |
Ontak injection (9/22/2011)
Company/Products | Reason | Related Information |
---|---|---|
Eisai 1-888-422-4743 150 mcg/mL, Eisai | Manufacturing issue | Eisai is working to have product available again. For information on Patient Access Program, please visit: http://www.ontak.com/ |
Orphenadrine Citrate Injection
Company/Products | Reason | Related Information | Updated |
---|---|---|---|
Akorn: 847-279-6100 30 mg/mL, 2 mL vial, 10 count (NDC 17478-0538-02) | Increased demand | Readily available. | Revised 3/16/2012 |
Bedford: Orphenadrine citrate injection 30 mg/mL Bedford | Bedford currently not producing. | ||
Sagent: 30 mg/mL, 2 mL vial, 10 count (NDC 25021-0651-02) | Available | Sagent has the 2mL presentation of orphenadrine citrate injection available. | Reverified 3/16/2012 |
Watson: 30 mg/mL, 2 mL vial, 10 count (NDC 00591-3222-47) | Information pending | Information pending |
Oxsoralen (methoxsalen) 1% topical lotion (7/6/2010)
Company/Products | Reason | Related Information |
---|---|---|
Valeant Pharmaceuticals International 1-866-819-9007 | Manufacturing delays | There is not yet an estimated release date. |
Oxymorphone Hydrochloride Oral Tablet (Initial Posting-3/19/2012)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Roxane Customer Service: 1-800-243-0127 5mg tablets, 100 count (NDC 00054-0283-25) 10mg tablets, 100 count (NDC 00054-0284-25) | Increase in market demand and API availability | RLI has accelerated production on this product and is projecting to have additional inventory available by end of April. | Revised 3/26/2012 |
Endo Pharmaceuticals Inc.
Opana (oxymorphone hydrochloride): 10mg tablet, 100 count bottle (NDC 63481-0613-70) 5mg tablet, 100 count bottle (NDC 63481-0612-70) Oxymorphone Hydrochloride: 10mg tablet, 100 count bottle (NDC 60951-0795-70) 5mg tablet, 100 count bottle (NDC 60951-0794-70) | Material shortage (API) | Temporarily unavailable and Endo cannot estimate a release date at this time. We will continue to provide updates as further information becomes available. | Revised 3/20/2012 |
Oxytocin Injection, USP (synthetic)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 10 mL MDV (10 USP units/mL) 1 mL SDV (Plastic Vial) (10 USP units/mL) 30 mL MDV (10 USP units/mL) | Increase in demand | 10 mL vial available. 1 mL vial available with an estimated release date of mid-March 2012. 30 mL vial back-ordered – release due early April. | Revised 3/12/2012 |
JHP Pharma 1-877-547-4547 1 mL vial (10 USP units/mL) 10 mL vial (10 USP units/mL) 10 mL vial (10 USP units/mL) | Increase in demand | 1 mL SDV is currently on short-term back-order. Company has increased production with an estimated release date of early February 2012.
10 mL vial in 1 and 25s: Available in adequate stock.
Please see product status memo: Short Term Backorder Status Letter (PDF - 95KB) | |
West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 1mL vial (10 USP units/mL) (NDC10019-291-02) 10 mL vial (10 USP units/mL) | Increase in product demand | West-Ward currently has limited quantities available of the 10 mL vial (10019-291-04). The 1 mL vial (10019-291-02 is currently on backorder. West-Ward has accelerated production and is expecting to have additional lots available for both presentations in the February - March 2012 timeframe. Product will be made available as it is released. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Sandoz: 1-800-525-8747 6 mg/mL injection 30 mg/5 mL vial (NDC 66578-0043-01) 100 mg/16.7 mL vial (NDC 66578-0043-02) 300 mg/50 mL vial (NDC 66578-0043-03) | Manufacturing delays | Sandoz is currently on backorder. | Reverified 3/16/2012 |
APP 1-888-386-1300 6 mg/mL injection 30 mg/5 mL vial (NDC 63323-0763-05)
| Increase in demand | APP is on intermittent back order and is releasing product as it becomes available. | Reverified 3/12/2012 |
Hospira Inc. Customer Service: 300 mg/50 mL vial (NDC 0409-0342-50) 30 mg/5 mL vial (NDC 0409-0342-09) 100 mg/16.7 mL vial (NDC 0409-0342-22) | Other Manufacturer Shortages/Market Withdrawal. | Product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand. Please check with your wholesaler for available inventory. | Revised 3/15/2012 |
Bedford Laboratories 1-800-562-4797 6 mg/mL injection 30 mg/5 mL vial (NDC 55390-0114-05) | Manufacturing delays | Bedford has all paclitaxel presentations on backorder and the company cannot estimate a release date. | |
Teva 1-800-545-8800 6 mg/mL injection 30 mg/5 mL vial (NDC 00703-4764-01) | Manufacturing delays | Teva has 30 mg/ 5 ml vial on backorder until April 2012. All other presentations are available with ample inventory. | Revised 3/15/2012 |
Sagent Pharmaceticals 1-866-625-1618 30mg/5mL 100mg/16.7mL 300mg/50mL | Sagent has the 5mL and 16.7mL on allocation and the 50mL product is available. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 1 mg/mL; 10 mL vial | Manufacturing delay | Products 1 mg/mL; 10 mL vial (NDC 0409-4646-01): next delivery May. | Reverified 3/16/2012 |
Pegasys (peginterferon alfa-2a) Injection - Prefilled Syringes (Initial Posting-3/26/2012)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Genentech Genentech Resource Center: 180 mcg/mL Pegasys Prefilled syringe (PFS) for single use NDC 0004-0352-39 | Increased demand and Manufacturing delays of the Pre-filled Syringes | Potential limited availability of the PFS form of 180 mcg/mL Pegasys in the next 6 months (NDC 0004-0352-39, NDC 0004-0357-30). The firm anticipates that the potential shortage of the PFS will resolve by September 2012.
Please see the Dear Health Care Provider Letter (PDF - 147KB) and the Dear Pharmacist Letter (PDF - 147KB)
The firm has adequate supplies of the following presentations of Pegasys: * 180 mcg/0.5 mL Autoinjector for single use (NDC 0004-0365-09) *135 mcg/0.5 mL Autoinjector for single use (NDC 0004-0360-09) * 180 mcg/mL Vial for single use (NDC 0004-0350-09) |
Pentostatin for Injection (Nipent) (Initial Posting - 3/21/2012)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 10 mg vial (NDC 0409-0801-01 | Other manufacturer shortage/market withdrawal. | Product 10 mg vial(NDC 0409-0801-01 ): next delivery April. Please check with your wholesaler for available inventory. | |
Bedford Customer Service 1-800-562-4797 10mg vial; ( NDC 55390-0244-01) | Manufacturing Delays | Bedford Laboratories has limited quantities available of pentostatin 10 mg lyophilized powder for injection (NDC 55390-0244-01) |
Perflutren Lipid Microsphere (DEFINITY ) Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Lantheus Medical Imaging 4 vial kit (NDC 11994-011-04) | Manufacturing delay | Lantheus will have Definity on back order and at this time the company cannot estimate a release date. | 3/23/2012 |
Phentolamine Mesylate for Injection (updated 12/2/2011)
Company/Products | Reason | Related Information |
---|---|---|
Bedford Customer Service: 1-800-562-4797 Phentolamine mesylate for injection, 5 mg lyophilized vial (NDC 55390-0113-01) | Manufacturing delay | Bedford has phentolamine on backorder and the company cannot estimate a release date. |
Phytonadione Injectable Emulsion (Vitamin K)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 1 mg/0.5 mL; 0.5 mL amp 10 mg/mL; 1 mL amp | Manufacturing delay | Product 1 mg/0.5 mL; 0.5 mL amp (NDC 0409-9157-01): next delivery March.
Product 10 mg/mL; 1 mL amp (NDC 0409-9158-01): next delivery March.
Please check with your wholesaler for available inventory. | Reverified 3/16/2012 |
Amphastar Pharmaceuticals, Inc./IMS 1-800-423-4136 Vitamin K injection, contains polysorbate 80 and propylene glycol 1 mg/0.5 mL, SAF-T-JET prefilled syringe (NDC 00548-1240-00) 1 mg/0.5 mL, MINIJET prefilled syringe (NDC 00548-1140-00) | Amphastar is not experiencing a shortage. This shortage is due to increased demand and Amphastar has increased production to meet demand. | Amphastar reports availability. Please note that Vitamin K injection, contains polysorbate 80 and propylene glycol. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc.
3 mMol/mL; 15 mL vial (NDC 0409-7295-01) | Return to market upon FDA request. | Product 3 mMol/mL; 15 mL vial (NDC 0409-7295-01): next delivery June. | Reverified 3/16/2012 |
American Regent/Luitpold 1-800-645-1706 3 mMol/mL, 5 mL vial (NDC 00517-2305-25) 3 mMol/mL, 15 mL vial (NDC 00517-2315-25) 3 mMol/mL, 50 mL vial (NDC 00517-2350-25) | Manufacturing delays | American Regent has the 50 mL vials available. The 5 mL vials and 15 mL vials are currently not being manufactured. | Reverified 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira Inc. Customer Service: 1-877-946-7747 100 mg/mL; 10 mL vial (NDC 0409-1902-01) 500 mg/mL; 2 mL vial (NDC 0409-1903-01) | Manufacturing delays | Product 500 mg/mL; 2 mL vial (NDC 0409-1903-01): next delivery in May. Product 100 mg/mL; 10 mL vial (NDC 0409-1902-01): ample levels of inventory to support market demand. Please check with your wholesaler for available inventory.
| Reverified 3/16/2012 |
Prochlorperazine Injection (1/30/2012)
Company/Products | Reason | Related Information |
---|---|---|
Bedford Customer Service 1-800-562-4797 5 mg/mL 2 mL vial, 10 count (NDC 55390-0077-10) 10 mL vial (NDC 55390-0077-01) | Manufacturing delays | Bedford has both prochlorperazine 5 mg/mL injection presentations on back order and the company cannot estimate a release date. The 2 mL vials are pending release while the 10 mL vials will not be manufactured until capacity permits.
|
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Hospira, Inc. Customer Service: 1-877-946-7747 25 mg/mL 1 mL | Manufacturing delay | Hospira has Promethazine 25 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date in 2013. | Reverified 3/16/2012 |
Teva Phamaceuticals 1-800-545-8800 25 mg/mL; 1 mL vial (NDC 00703-2191-04) 50 mg/mL; 1 mL vial (NDC 00703-2201-04 | Manufacturing delay | Teva has all promethazine injection presentations on back order and the company cannot estimate a release date. | Reverified 3/15/2012 |
West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 (Formerly a Baxter Product) 25 mg/mL;1 mL dosette ampule (NDC 00641-1495-35) 25 mg/mL; 1 mL ampule (NDC 60977-0001-01) | Increase in product demand. | West-Ward is currently experiencing a backorder situation on Promethazine 25 mg/mL,1 mL vial, 50 mg/mL, 1 mL ampul and Phenergan 25 mg/mL, 1 mL vial. All other codes are available in limited quantities. West-Ward has accelerated production and will have units of all presentations available for release in the March – April 2012 timeframe. Product will be made available as it is released | Revised 3/19/2012 |
Protonix (pantoprazole) Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Pfizer Injectables 1-800-533-4535 40 mg vial, package of 10 (NDC 00008-0923-55) 40 mg vial, package of 25 (NDC 00008-0923-60) 40 mg Novaplus vial, package of 10 (NDC 00008-0941-04) | Manufacturing delays | Pfizer has resumed shipping of Protonix 40mg in 10 (00008-0923-55) and Novaplus 40mg in 10 (00008-0941-04) on March 14th Pfizer has limited supply of 40mg in 25 (00008-0923-60) until June 2012. | Revised 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent/Luitpold 1-800-645-1706 40 mcg/mL, 10 mL vial (NDC 00517-6610-25) | Manufacturing delays | American Regent has Selenium Injection on back order and the company cannot estimate a release date. | Reverified 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 2 mEq/mL, 100 mL vial (NDC 63323-0032-61) | Increased in demand | APP has sodium acetate on back order and estimates a release date in late-March. | Revised 3/12/2012 |
American Regent, Inc./Luitpold 2 mEq/mL, 20 mL vial (NDC 00517-2096-25) 2 mEq/mL, 100 mL vial (NDC 00517-2500-25) 4 mEq/mL, 50 mL vial (NDC 00517-5023-25) | Manufacturing delays | American Regent has the 20 mL vials currently on back order. American Regent anticipates to have the 50 mL vial available end of March 2012. The 100 mL vial has been discontinued. | Revised 3/19/2012 |
Sodium Bicarbonate Injection (Initial Posting-3/20/12)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Amphastar Pharmaceuticals Inc. Customer Service: 1-800-423-4136 Sodium Bicarbonate Injection USP, 8.4%, 50 mL Prefilled Syringe NDC: 0548-3352- | Increased Demand due to competitor backorders | Next release on March 26, 2011 Additional release anticipated on April 5, 2011. | |
APP 1-888-386-1300 Sodium Bicarbonate Injection 4.2% 5 mL vial (NDC 63323-0026-05 | Increased demand | APP is currently back-ordered and expects a release late March. Please check wholesalers for inventory. | |
Hospira, Inc. Customer Service: 1-877-946-7747 4%; 5 mL vial (NDC 0409-6609-02) 0.5 mEq/mL; 10 mL Abboject (NDC 0409-5534-34) 0.9 mEq/mL; 50 mL Abboject (NDC 0409-4916-34) 1 mEq/mL; 50 mL vial (NDC 0409-6625-02) 1 mEq/mL; 50 mL Abboject (NDC 0409-6637-34) 1 mEq/mL; 10 mL Abboject (NDC 0409-4900-34 | Manufacturing delay; Other manufacturer shortages/market withdrawal. | Product 4%; 5 mL vial (NDC 0409-6609-02): next delivery April. Product 0.5 mEq/mL; 10 mL Abboject (NDC 0409-5534-34): next delivery April. Product 0.9 mEq/mL; 50 mL Abboject (NDC 0409-4916-34): next delivery March. Product 1 mEq/mL; 50 mL vial (NDC 0409-6625-02): next delivery April Product 1 mEq/mL; 50 mL Abboject (NDC 0409-6637-34): next delivery March. Product 1 mEq/mL; 10 mL Abboject (NDC 0409-4900-34): next delivery April. Please check with your wholesaler for available inventory |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 30 mL vials (NDC 63323-0087-30) | Increased demand | APP has sodium chloride 23.4% solution for injection on intermittent back order and the company is releasing product as it becomes available. | Reverified 3/12/2012 |
American Regent/Luitpold 1-800-645-1706 30 mL vials (NDC 00517-2930-25), 100 mL vials (NDC 00517-2900-25) | Unavailable | American Regent/Luitpold is no longer manufacturing Sodium Chloride Injection 23.4%. | Reverified 3/19/2012 |
Hospira Inc. Customer Service: 1-877-946-7747 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02) | Manufacturing delay | Product 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02): expected availability is TBD. Product 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02): expected availability is TBD. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Akorn: 847-279-6100 Sufenta 50 mcg/mL 1 mL ampule (NDC 17478-0050-01) 2 mL ampule (NDC 17478-0050-02) | Material Shortage | 1 mL ampoule (NDC 17478-0050-01)-Releasing mid-April 2 mL ampoule (NDC 17478-0050-02)-Releasing next week (week of March 19th) 5 mL ampoule (NDC 17478-0050-05)-Targeted release in May | 3/16/2012 |
Hospira, Inc. Sufentanil 50 mcg/mL
| Manufacturing delay | Product 50 mcg/mL; 1 mL vial (NDC 0409-3382-21): next delivery August. Product 50 mcg/mL; 2 mL vial (NDC 0409-3382-22): next delivery August. Product 50 mcg/mL; 5 mL vial (NDC 0409-3382-25): next delivery August. Product 50 mcg/mL; 1 mL ampule (NDC 0409-3380-31): next delivery September. Product 50 mcg/mL; 2 mL ampules (NDC 0409-3380-32). next delivery September Product 50 mcg/mL; 5 mL ampule (NDC 0409-3380-35): next delivery July. Please check with your wholesaler for all available inventory. | Revised 3/15/2012 |
West-Ward (formerly Baxter products) Customer Service: 1-888-229-0001 Sufentanil 50 mcg/mL 2 mL ampule (NDC 10019-0050-21) 5 mL ampule (NDC 10019-0050-06) | Increase in product demand due to market supply issues. | West-Ward is currently experiencing a backorder situation on all presentations due to an increase in market demand. Multiple lots of the 5 mL ampul are anticipated to be released and available in the April - May 2012 timeframe. No update is available at this time on the availability of the 1 mL and 2 mL ampuls, | Revised 3/19/2012 |
Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals
80 mg/trimethoprim 16 mg/mL injection | Teva recalled Lot #31308526B/Exp. Date 9/2012 of SMX/TMP Injection 10 ml vials to the retail level because some vials may have defective crimps. | Teva is reviewing orders for sulfamethoxazole/trimethoprim injection in 5ml and 10 ml vials, and these are available for drop shipment only. The 30ml vials are on back order and the company estimates a release date in third quarter of 2012. | Reverified 3/15/2012 |
Telavancin (Vibativ) Injection (updated 1/6/2012)
Company/Products | Reason | Related Information |
---|---|---|
Astellas Pharma US, Inc. 1-800-727-7003 NDC 00469-3575-50 NDC 00469-3525-30 | Manufacturing delays | Astellas has no estimated date of availability.
|
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals 1-800-545-8800 250 mg, 100 count (NDC 00172-2416-60) 250 mg, 100 count unit dose (NDC 00172-2416-10) 250 mg, 1000 count (NDC 00172-2416-80) 500 mg, 100 count (NDC 00172-2407-60) 500 mg, 100 count unit dose (00172-2407-10) 500 mg, 1000 count (NDC 00172-2407-80) | Manufacturing delays | Teva has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date. | Reverified 3/2/2012 |
Watson Customer Service: (973) 355-8300 250 mg, 100 count (NDC 00591-2234-01) 250 mg, 1000 count (NDC 00591-2234-10) 500 mg, 100 count (NDC 00591-2235-01) 500 mg, 1000 count (NDC 00591-2235-10) | Manufacturing delays | Watson has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date. |
Thiotepa for Injection (updated 12/2/2011)
Company/Products | Reason | Related Information |
---|---|---|
Bedford Laboratories Customer Service 1-800-562-4797 15 mg/mL vial (NDC 55390-0030-10) | Manufacturing delays | Bedford has thiotepa on backorder and the company cannot estimate a release date. |
Adienne | Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 1MB) for information about emergency supplies that are now available to help address the shortage. |
Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated 11/22/2011)
Company/Products | Reason | Related Information |
---|---|---|
Genzyme Corporation 1-800-745-4447 | Temporary Delays | Intermittent shipments of the product have resumed globally. Genzyme continues to expect that Thyrogen supply constraints will occur through 2012. |
Thyrolar Tablets (12/31/2009)
Company/Products | Reason | Related Information |
---|---|---|
Forest Pharmaceuticals | Manufacturing delays | Forest has not yet reported when Thyrolar will be available. |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals 1-800-545-8800 250 mg, 100 count (NDC 00093-0154-01) | Manufacturing delays | Teva has ticlopidine tablets in stock. | Revised 3/2/2012 |
Apotex Corporation Customer Service: 1-(877)-4-Apotex 250 mg, 30 count (NDC 60505-0027-02) 250 mg, 60 count (NDC 60505-0027-04) 250 mg, 500 count (NDC 60505-0027-07) | Manufacturing delays | Apotex has ticlopidine tablets on back order and the company estimate a release date of May, 2012. | Revised 3/2/2012 |
Tobramycin Solution for Injection
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Teva Pharmaceuticals 40 mg/mL, 2 mL vial (NDC 00703-9402-04)
40 mg/mL, 30 mL vial (NDC 00703-9416-01) | Manufacturing delays | Teva has all tobramycin 40 mg/mL solution for injection on long term back order and the company cannot estimate a release date. | Reverified 3/15/2012 |
Pfizer Injectables 40 mg/mL, 2 mL vial (NDC 00069-0088-02)
40 mg/mL, 30 mL vial (NDC 00069-0091-03) | Manufacturing delays | Pfizer tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company estimates a release date of April 2012. | |
APP 10 mg/ml; 2ml vial (NDC 63323-0305-02) 40 mg/mL, 2 mL Novaplus vial (NDC 63323-0306-55) Tobramycin Lyophilized Powder for Injection | Increase in demand/manufacturing delays | APP has available tobramycin 1.2 gram lyophilized powder for injection presentations. Please check wholesaler inventory. The 40 mg/mL 2 mL vials are available – check wholesalers for inventory. APP has tobramycin solution for injection 10 mg/mL 2 mL vials on intermittent back order. Product may be available at wholesalers. The 40 mg/mL 50 mL vials are available. Please check wholesaler inventory. | Revised 3/12/2012 |
Hospira, Inc. Customer Service 1-877-946-7747 10 mg/mL; 2 mL vial 40 mg/mL; 2 mL vial 40 mg/mL; 50 mL vial | Other manufacturer shortage/market withdrawal. | Product 10 mg/mL; 2 mL vial (NDC 0409-3577-01): next delivery June. . | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent/Luitpold 1-800-645-1706 20 units/mL; 0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25) 20 units/ml; 1 mL multi-dose vial, 25 count (NDC 00517-1020-25) 20 units/ml; 10 mL multi-dose vial, 25 count (NDC 00517-0410-10) | American Regent has 0.5 mL multi-dose vial available. 1 mL multi-dose vial on back order and will be available end of April 2012. 10 mL multi-dose vial on back order and will be available end of April 2012. | Revised 3/19/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Bedford Laboratories Customer Service 1-800-562-4797 | Increase in demand | Bedford has all vecurionium presentations on backorder and the company cannot estimate a release date. | |
Sun Pharmaceutical Industries, Inc. 1-800-818-4555 | Increase in demand | Sun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available. Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44 Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44 | |
Teva Pharmaceuticals
10 mg vials, package of 10 (NDC 00703-2914-03) | Manufacturing delay | Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on long term backorder and the company cannot estimate a release date. | Reverified 3/15/2012 |
Hospira, Inc. Customer Service: 1-877-946-7747 10 mg vial (NDC 0409-1632-01)
20 mg vial (NDC 0409-1634-01) | Manufacturing delay | Product 20 mg vial (NDC 0409-1634-01): next delivery March 2012. Product 10 mg vial (NDC 0409-1632-01): temporarily suspended. | Reverified 3/16/2012 |
Sagent Pharmaceticals 1-866-625-1618 10mg/vial
20mg/vial | Sagent has both the 10mg and 20mg product available. | Reverified 3/16/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
APP 1-888-386-1300 1 mg/mL; 10 mL vial (NDC 63323-0278-10) | Increased demand | APP has vinblastine sulfate injection on back order with an estimated release date of late-March 2012. | Revised 3/12/2012 |
Voltaren gel 1% (Diclofenac Sodium Topical Gel) (Initial posting-2/7/2012)
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
Novartis Consumer Health, Inc. Customer Service: 1-800-452-0051 or 1-888-477-2403 100 gram, 3 count (NDC 63481-0684-03) | Manufacturing delay | Manufacturer started to release Voltaren Gel 1% (March 23, 2012). However, Drug shortage remains in effect-Novartis will provide further updates as new information becomes available. | Revised 3/27/2012 |
Company/Products | Reason | Related Information | Date Updated |
---|---|---|---|
American Regent/Luitpold 1-800-645-1706 1 mg/mL, 10 mL vial 5 mg/mL, 5 mL vial 100 gram, 3 count 100 gram, 5 count | Manufacturing delay | American Regent has all presentations of zinc sulfate on back order with no estimated release date. | Reverified 3/19/2012 |
Hospira, Inc. Customer Service: 1-877-946-7747 1 mg/mL, 10 mL vial | Manufacturing delay | Product 1 mg/mL, 10 mL vial (NDC 0409-4090-01): next delivery March. Please check with your wholesaler for all available inventory. | Reverified 3/16/2012 |
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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#perflutren