Current Drug Shortages: Oxytocin Injection, USP (synthetic)
Thursday, 22 December 2011 12:55
Acetylcysteine Inhalation Solution (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 2012.
Product 200 mg/mL; 30 mL vial (NDC 0409-3308-03): next delivery March, 2012.
Please check with your wholesaler for available inventory. |
| Roxane Laboratories 1-614-276-4000 200 mg/mL, 10 mL (NDC 00054-3028-02), 200 mg/mL, 30 mL (NDC 00054-3026-02) | Increase in demand | Roxane Laboratories anticipates releases for emergency shipments in December 2011 for acetylcysteine inhalation solution 100 mg/mL, 10 mL (NDC 00054-3027-02) and 200 mg/mL, 10 mL (NDC 00054-3026-02) vials. Roxane Laboratories anticipates releases for emergency shipments in January 2012 for 100 mg/mL, 30 mL (NDC 00054-3025-02) and 200 mg/mL, 30 mL (NDC 00054-3028-02) vials. |
| 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. |
Alcohol Dehydrated (Ethanol > 98%) (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent/Luitpold: 631-924-4000 1 mL ampule, package of 10 (NDC 00517-8571-10); 5 mL ampule, package of 10 (NDC 00517-8575-10) | Manufacturing delays | 1ml ampules being released. |
| Akorn Pharmaceuticals 1-800-932-5676 (NDC 17478-0503-05) | n/a | Akorn has Alcohol Dehydrated (Ethanol > 98%) available in a 5 mL vials. |
Amikacin Injection (updated 12/2/2011)
| Company | Reason | Related Information |
|---|---|---|
Teva Pharmaceuticals | Manufacturing delays | Teva has amikacin 250 mg/mL 4 mL vials available for drop shipment (NDC 00703-9040-03). |
| 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. |
Aminocaproic Acid (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 250 mg/mL; 20 mL vial | Other Manufacturer Shortage/Market Withdrawal | Product 250 mg/mL; 20 mL vial (NDC 0409-4346-73): next delivery January, 2012.
|
| American Regent/Luitpold 631-924-4000 | Manufacturing delays | Aminocaproic Acid Injection, USP 250 mg/mL, 20 mL vial (NDC 00517-9120-25) has been released as of October 4, 2011. |
Ammonium Chloride Injection (updated 10/31/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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. |
Ammonium molybdate injection (5/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
American Regent/Luitpold 631-924-4000 American Regent Molybdenum 25 mcg/mL, 10 mL vial (NDC 00517-6610-25) | Manufacturing delays | American Regent has ammonium molybdate injection on back order and the company cannot estimate a release date. |
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 11/15/2011)
| 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 00555-0764-02) | API supply issues | Teva continue to release product as it becomes available. |
Anadrol-50 tablets (Oxymetholone Tablets) (updated 12/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Meda Pharmaceuticals Inc.: 732-564-2200 50 mg (bottles of 100) - NDC 68220-055-10 | This shortage is due to Active Pharmaceutical Ingredient (API) constraints. | Meda estimates that Anadrol may be available March 2012. |
Aquasol A (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 2Q 2012. |
Atropine Sulfate Injection (updated 12/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 February 2012.
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. |
| American Regent/Luitpold 631-924-4000 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) | American Regent had temporarily suspended manufacture of most drug products in April, 2011 | No stock available. Anticipate to have lots available March 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.
West-Ward has accelerated production on this product and is projecting to have several lots available by the end of December 2011.
Product will be made available as it is released |
Avalide (irbesartan and hydrochlorothiazide)Tablets (3/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bristol-Myers Squibb 1-800-321-1335 | Manufacturing delays | Please see the following link for updated information: Bristol-Myers Squib |
Bleomycin Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20) | Increased demand | APP has Bleomycin 15 units and 30 units presentations on back order. Releases on both presentations are expected in early January 2012. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva-Sicor has available bleomycin 15 unit (NDC 00703-3154-01) vials. They are reviewing orders prior to release. |
| Bedford 1-800-562-4797 15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01) | Product discontinued | Bedford currently has all presentations discontinued. |
Hospira Inc. Customer Service: 15 unit vial (NDC 61703-0332-18) 30 unit vial (NDC 61703-0323-22) | Other Manufacturer Shortages/Market Withdrawal | Product 15 unit vial (NDC 61703-332-18): next delivery January 2012.
|
Bupivacaine Hydrochloride Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
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 January 2012.
Product 0.5%; 50 mL vial (NDC 0409-1163-01): next delivery January 2012.
Product 0.75%; 10 mL vial (NDC 0409-1165-01): next delivery January 2012.
Product 0.75%; 30 mL vial (NDC 0409-1165-02): next delivery January 2012.
Product 0.5% w/epi 1:200,000; 10 mL vial (NDC 0409-9045-01): next delivery April 2012.
Product 50 mg/20 mL Sterile pack amp (NDC 0409-4272-01) next delivery January 2012.
Please check with your wholesaler for available inventory. |
Buprenorphine injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 | API supply constraints; require FDA approval of a new API supplier | Hospira is working through FDA to gain approval of the new API supplier in order to resume production. |
| American Regent 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 long term back order and the company cannot estimate a release date. |
| 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. |
Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL) 
(11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent/Luitpold: 631-924-4000 American Regent 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. |
Calcitriol 1 mcg/mL Injection (updated 11/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent, Inc. 1-800-645-1706 1 mL ampule, 25 count (NDC 00517-0132-25) | Increased demand | American Regent has calcitriol injection on back order and the company cannot estimate a release date. |
| APP Pharmaceuticals 1-888-386-1300 1 mL ampule, 50 count (NDC 63323-0731-01 | Increase in demand | APP has Calcitriol injection on back order and plans releases in early December. |
| Abbott Laboratories 1-800-255-5162 1 mL ampule, 100 count (NDC 00074-8110-31) | Manufacturing delays | Abbott has Calcijex 1 mcg/mL injection on back order with an estimated release date in October 2011. |
| 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 | Akorn has calcitriol 1 mcg/mL 1 mL ampules in 10-packs available to order. |
Calcium Chloride Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Manufacturing delay | Product 100 mg/mL; 10 mL Abboject (NDC 0409-4928-34): next delivery January 2012. Product 100 mg/mL; 10 mL Ansyr (NDC 0409-1631-10): next delivery January 2012.
Please check with your wholesaler for available inventory. |
| American Regent, Inc. 1-800-645-1706 | American Regent, Inc. is not currently releasing Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial. Information on releases will be posted once available. | |
| 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. |
Calcium Gluconate (updated 6/24/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 100 mg/mL vials, 10 mL vials (NDC 63323-0311-10)50 mL vials (NDC 63323-0311-50) 100 mL vials (NDC 63323-0311-61) | Increased Demand | APP has calcium gluconate 100 mg/mL - 100 mL (63323-311-61) & 100mg/mL- 50 mL (63323-311-50) vials on intermittent back order due to increased demand and the company is releasing the product as it becomes available. The 100 mg/mL- 10mL (63323-311-10) vials are being allocated. The 200 mL vials have been discontinued. |
| Luitpold 631-924-4000 50 mL (NDC 0051703950-25), and 100 ml NDC (00517-3900-25) vials | Increase in demand | American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order. The 10 mL vials have been discontinued. |
Cerezyme (imiglucerase for injection) (9/16/2011)
Chromic Chloride Injection (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 March 2012. |
| American Regent/Luitpold 631-924-4000 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. |
Cisplatin injection 1 mg/mL solution (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 | Increased Demand | APP is continuing to allocate as releases occur: 50 mL vial (NDC 63323-0103-51), 100 mL vial (NDC 63323-0103-65) and 200 mL vial (NDC 63323-0103-64). |
| 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. |
| Bedford 1-800-562-4797 | Product discontinued | Bedford currently has all presentations discontinued. |
Cosyntropin Injection
(12/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Mylan Institutional 1-888-258-4199 0.25mg/ml (NDC 10139-0905-02); packages of 10 (NDC 10139-0905-10) | Manufacturing delays | Anticipates availability in mid-late January. |
| Sandoz Customer Service: 1-609-627-8500 0.25mg/ml (NDC 00871-23052-71); Package of 10 (NDC 00781-3052-95) | Information pending | Information pending |
Cyanocobalamin injection (updated 9/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP Pharmaceuticals 1-888-386-1300 1000 mcg/mL, 1 mL vial (NDC 63323-0044-01) | Increase in demand | APP has cyanocobalamin injection on intermittent back order and the company is releasing product as it becomes available. |
| American Regent, Inc. 1-800-645-1706 1000 mcg/mL, 1 mL vial (NDC 00517-0031-25), 1000 mcg/mL, 10 mL vial (NDC 00517-0032-25) 1000 mcg/mL, 30 mL vial (NDC 00517-0130-05) | Manufacturing delays | American Regent has 1ml and 10 ml vials being released the week of September 26th. |
Daunorubicin hydrochloride solution for injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13) | Manufacturing issues | Teva has daunorubicin solution for injection on back order and estimates a release date of August, 2011. |
| Bedford Customer Service 1-800-562-4797 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 has all daunorbucin presentations on back order and the company cannot estimate a release date. |
Desmopressin Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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) | n/a | Ferring is continuing to release product as soon as it becomes available. |
| 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 January 2012. Please check with your wholesaler for available inventory.
|
| Sanofi-Aventis 1-800-981-2491 (DDAVP 4 mcg/mL 1 mL (NDC 00075-2451-01) and 10 mL (NDC 00075-2451-53)) | Unanticipated increased demand | Desmopressin 4 mcg/mL, 1 mL (NDC 00075245101) ampule is available.
Desmopressin 4 mcg/mL,10 mL (NDC00075245153) vials will be available in Mid December. |
| 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 available desmopressin 4 mcg/mL 1 mL (NDC 00703-5051-03) and 10 mL (NDC 00703-5054-01) vials and is reviewing orders prior to release. |
Dexamethasone Injection (updated 11/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent Inc. (1-800-645-1706) | Manufacturing issues | American Regent has recalled a number of their dexamethasone 4 mg/mL presentations due to the presence of particulate matter. The firm has placed their product on hold with no estimated release date. |
| APP (1-888-386-1300) | APP has dexamethasone injection on allocation due to increased demand for the product. | APP has Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL SDV (NDC 63323-165-01), 4 mg/mL, 5 mL SDV (NDC 63323-165-05), 4 mg/mL, 30 mL MDV (NDC 63323-165-30), 10 mg/mL, 1 mL SDV (NDC 63323-506-01), 10 mg/mL, 10 mL MDV (NDC 63323-516-10) presentations available. |
| West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 (Formerly a Baxter Product) 1 mL vial | Unexpected increase in product demand due to market supply issues. | West-Ward is currently experiencing a backorder situation on the 10 mg/mL, 1 mL vial (NDC 0641-0367-25). West-Ward has accelerated production and will have product available by the middle of July. Additional lots are scheduled to be released by the end of August. |
Diazepam Injection (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 5 mg/mL; 2 mL Carpuject (0409-1273-32) 5 mg/mL; 10 mL vial | Carpuject: Material shortage. Vial: Manufacturing delay. | Product 5 mg/mL; 2 mL Carpuject (0409-1273-32): next delivery March 2012.
Product 5 mg/mL; 10 mL vial (0409-3213-12): next delivery April 2012. |
Digoxin Injection (updated 6/24/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 (Formerly a Baxter Product) USP 250 mcg/mL, 2 mL ampuls (NDC 0641-1410-35) | Increase in product demand | West-Ward is currently experiencing a back order situation on the 2 mL ampuls (NDC 0641-1410-35) due to unforeseen demand driven by competitors' supply issues. West-Ward has accelerated production and will have product available by the end of July – beginning of August. |
| Sandoz Customer Service: 1-609-627-8500 USP 250 mcg/mL, 2 mL (NDC 0781-3059-95) | Manufacturing delays | Sandoz anticipates supply in 3Q 2011. |
| GlaxoSmithKline Customer Service: 888-825-5249 Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35) | Manufacturing delays | GSK has discontinued the manufacturing Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35) 250 mcg/mL, 2 mL (10s - NDC 00173-0260-10) is currently on back-order and should be available January 2012. |
Diltiazem Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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) | Higher than anticipated market demand.
| Product 5 mg/mL; 2 mL Carpuject (0409-1273-32): next delivery February 2012.
Product 5 mg/mL; 10 mL vial (0409-3213-12): next delivery April 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 | Akorn has product available. |
Diphenhydramine Hydrochloride Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 50 mg/ml, 1 ml (NDC 63323-0664-01) | Increased in demand | APP has increased production in an effort to meet market demand by January. |
| 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. |
| 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. |
| 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 to have several lots available by the middle of December 2011. Product will be made available as it is released. |
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 (updated 10/28/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Janssen Products, LP (formerly Centocor Ortho Biotech Products, L.P.)-1-800-526-7736 (1-800-JANSSEN) 2 mg/mL, 10 mL (NDC 17314-9600-01); 25 ml (NDC 17314-9600-02) | Manufacturing delays | Estimated Availability 3rd Quarter, 2011. Janssen Biotech, Inc. has announced an allocation process for physicians to obtain Doxil supply. This information will be available on both the company website and that of its DOXIL Brand. Please see http://www.doxil.com/sites/default/files/DHCP_september2011.pdf |
Doxorubicin Solution for Injection (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 1-800-545-8800 | Manufacturing delays | Teva plans to have doxorubicin solution for injection, 2 mg/mL 5 mL vial (NDC 00703-5043-03) 25 mL vial (NDC 00703-5046-01) 100 mL vial (NDC 00703-5040-01) available again in early 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 (12/10/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 - 588KB) for additional information. |
Etoposide solution for injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 1-800-545-8800 | Manufacturing delays | Teva has Toposar 20 mg/mL solution for injection 5 mL (NDC 00703-5653-01) 25 mL and 50 mL vials on back order - Teva is working on having additional supplies as soon as possible. |
| APP 1-888-386-1300 | Manufacturing delays | APP is releasing all etoposide solution for injection 20 mg/mL presentations as they become available. |
| 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 20mg/5mL, 100mg vial (NDC#16729-114-31) | N/A | Accord healthcare has product available. |
Fabrazyme (agalsidase beta) (updated 9/7/2011)
Fentanyl Citrate Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 2012 (new product).
________
Product 0.05 mg/mL; 2 mL Carpuject (0409-1276-32): next delivery January 2012.
Carpuject orders (NDC 0409-1276-32) may be placed direct or through the wholesaler, and will be filled in the order in which received. |
| 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 | West-Ward is currently experiencing a backorder situation on all presentations due to unforeseen demand driven by competitor supply issues. West-Ward has accelerated production and will have the following products available. Lots of the 2 mL, 5 mL, and 20 mL ampul products will be released and available in November 2011. Additional lots of the 2 mL, 5 mL, 20 mL, and 50 mL vials are scheduled to be manufactured and available in the November – December 2011 timeframe. Product will be made available as it is released. |
Fluorouracil Injection (11/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva has all fluorouracil injection presentations on back order and the company estimates a release date of 4th quarter, 2011. |
| APP 1-888-386-1300 | Increased demand | APP has Fluorouracil injection 50 mg/mL, 10 mL vials on allocation (NDC63323-117-10), 50 mg/mL, 50 mL vials are available (NDC 63323-117-51), 50 mg/mL, 20 mL (NDC 63323-117-20) & 100 mL (63323-117-61) vials on intermittent back-order and the company is releasing product as it becomes available. |
Foscarnet Sodium Injection (updated 9/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service 1-877-946-7747 24 mg/mL; 250 mL bottle 24 mg/mL; 500 mL bottle | Manufacturing delays | Hospira is working to resolve the manufacturng delay and additional information on availability will be forthcoming. |
| Clinigen Healthcare | Please see attached Dear Healthcare Professional Letter (PDF - 519KB) for updated information regarding distribution. |
Fosphenytoin Sodium Injection (updated 11/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories 1-800-562-4797 | Not currently marketed | Product Discontinued: Bedford currently has all presentations discontinued. |
| Hospira Customer Service: 1-877-946-7747 75 mg/mL; 2 mL vial 75 mg/mL; 50 mL vial | Manufacturing delay | Both presentations are temporarily discontinued. |
| Akorn Pharmaceuticals 1-800-932-5676 | Not currently marketed | Akorn will be off the market for an period of time. |
| APP 1-888-386-1300 | Increase in demand | APP has all presentations available. |
| West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 | Increase in demand | West-Ward has available NDC# 0143-9788-25 fosphenytoin 150 mg/2ml and NDC# 0143-9782-10 fosphenytoin 750 mg/10 ml. |
| American Regent, Inc. 1-800-645-1706 | Newly launched product | American Regent reports availability of fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25). |
Furosemide Injection (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 10 mg/mL; 4 mL Ansyr syringe 10 mg/mL; 10 mL Ansyr syringe 10 mg/mL; 2 mL vial 10 mg/mL; 4 mL vial 10 mg/mL; 10 mL vial | Manufacturing delay | All presentations: ample levels of inventory to support market demand.
|
| American Regent, Inc. 1-800-645-1706 | Increase in demand | American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end use. |
| APP 1-888-386-1300 | Increase in demand | APP has available furosemide 10 mg/mL injection 2 mL (NDC 63323-0280-02) and 4 mL (NDC 63323-0280-04) vials. |
Haloperidol Decanoate Injection (updated 12/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva has all presentations on back order. |
| Ortho-McNeil Janssen 1-800-526-7736 | See Related Information | Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14). |
| APP Pharmaceuticals 1-888-386-1300 | See Related Information | APP has available Haloperidol Decanoate 50mg/mL, 5 mL vials (NDC 63323-0469-05), and and 100mg/mL, 5 mL (NDC 63323-0471-05) vials. The 100 mg/mL 1 mL (NDC 63323-0471-01) & 50 mg/mL 1 mL (NDC 63323-0469-01) presentations are on backorder and the company is releasing product as it becomes available. |
| Bedford Laboratories Customer Service 1-800-562-4797 | Product discontinued | Bedford has all presentations of the Haloperidol Decanoate discontinued. |
Patriot Pharmaceuticals, LLC. 50 mg/mL Injection, 1 mL Ampules (NDC: 10147-0921-3)
100 mg/mL Injection, 1 mL Ampules (NDC: 10147-0922-5) | N/A | Patriot Pharmaceuticals has product available for ordering. |
| Sagent Pharmaceticals 1-866-625-1618 5mg/mL 1mL vial NDC 25021-806-01 5mg/mL 10mL multidose vial | Sagent has both the 1mL and 10mL products available. |
Indigo carmine injection
(12/12/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Akorn Pharmaceuticals 1-800-932-5676 8 mg/mL, 5 mL ampule | Increase in demand | Akorn has indigo carmine available and releasing product as it becomes available. |
| American Regent, Inc. 1-800-645-1706 8 mg/mL, 5 mL ampule | Manufacturing delays | American Regent has indigo carmine on back order and the company cannot estimate a release date. |
Insulin glulisine [rDNA origin] injection) solution for injection (Apidra SoloStar)
(10/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sanofi-Aventis 1-800-981-2491 | Manufacturing delays | Product to be available 1st quarter 2012. Please note Apidra vials are not impacted by this shortage. |
Intravenous Fat Emulsion (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 that led to the shortage. |
| 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) |
Isoniazid Tablets (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 (300 mg - 30s - 00143-1261-30, 100s - 00143-1261-01, 1000s - 00143-1261-10; 100mg - 100s - 00143-1260-01, 1000s - 00143-1260-10) | Increase demand | Releases planned for September and November |
| 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 |
| 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 |
Ketorolac Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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
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) | American Regent/Luitpold is currently not manufacturing Ketorolac Tromethamine Injection, USP | |
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 late-January, 2012. The 30 mg/mL 1 mL vial 10 count presentation is on back order and the company cannot estimate a release date. |
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. |
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 for all except NDCs 0409-2287-31 and 0409-2287-61, which is Manufacturing Delay. | Product 15 mg/mL; 1 mL vial (NDC 0409-3793-01): next delivery February 2012.
Product 15 mg/mL; 1 mL Carpuject (NDC 0409-2288-31): next delivery January 2012.
Product 30 mg/mL; 1mL vial (NDC 0409-3795-01): next delivery January 2012.
Product 30 mg/mL; 1 mL Carpuject(NDC 0409-2287-31): next delivery March 2012.
Product 30 mg/mL; 2 mL Carpuject (NDC 0409-2287-61): next delivery March 2012.
Product 60 mg/mL; 2 ml vial (NDC 0409-3796-01); next delivery December. |
Labetalol Hydrochloride Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Bedford Customer Service | Manufacturing delays | Bedford has all labetalol presentations on backorder and the company cannot estimate a release date. |
| Akorn Customer Service 1-800-932-5676 Labetalol injection 5 mg/mL 20 mL vials (NDC 17478-0420-20) 40 mL vials (NDC 17478-0420-40) | Increased demand | Akorn is releasing product as it becomes available and has increased production to meet current increased demand. |
| Hospira, Inc. Customer Service: 1-877-946-7747 5 mg/mL; 20 mL vial (0409-2267-20) 5 mg/mL; 40 mL vial (0409-2267-54) 5 mg/mL; 4 mL syringe (0409-2339-34) | Higher than anticipated market demand | All presentations: next delivery January 2012. Please check with your wholesaler for all available inventory. |
| Sagent pharmaceuticals, Inc. 866-625-1618 20 mL vials (NDC 25021-0300-20) 40 mL vials (NDC 25021-0300-40) | Increased demand | Sagent has the 20mL and 40mL products on allocation. |
L-cysteine hydrochloride (10/18/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
American Regent/Luitpold 50 mg/mL | Manufacturing delays | American Regent has L-cysteine hydrochloride injection on back order and the company cannot estimate a release date. |
| Sandoz Customer Service: 1-609-627-8500 50 mg/mL | Increased demand | Sandoz has L-cysteine hydrochloride injection 50 mL and 10 mL vials on back order and the company estimates a release date of end of November, 2011. |
Leucovorin Calcium Lyophilized Powder for Injection (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
| APP Pharmaceuticals 1-888-386-1300 | Increased demand | APP is currently back-ordered due to increased demand. Intermittent releases expected Q1-2012. (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV). |
Leuprolide Injection (updated 7/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva 1-800-545-8800 1 mg/0.2 ml (NDC 00703-4014-18) | Manufacturing delays | Currently on backorder, anticipate release is Q411. |
| Sandoz 1-609-627-8500 1 mg/0.2 ml (NDC 00185-7400-85) | Increase in demand | On intermittent backorder, anticipate release October 2011. |
| Caraco 313-871-8400 1 mg/0.2 ml (NDC 41616-0936-40) | Increase in demand | On intermittent backorder. |
Levaquin Injection (updated 12/6/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Janssen Pharmaceuticals, Inc.:
Levaquin Injection 250 mg in 50 mL Dextrose 5%, premix bag (NDC 50458-0167-01) 500 mg in 100 mL Dextrose 5%, premix bag (NDC 50458-0168-01) 750 mg in 150 mL Dextrose 5%, premix bag (NDC 50458-0166-01) | Manufacturing delays | Janssen Pharmaceuticals, Inc. is experiencing intermittent back orders on all Pre-mixed IV bag presentations of Levaquin due to manufacturing delays and are releasing product as it becomes available. |
Levofloxacin Injection (updated 12/12/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 | Akorn has levofloxacin 25 mg/mL 20 mL and 30 mL vials on intermittent back order and the company is releasing product as it becomes available. |
| 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 all 3 strengths available for contracted customers only. Additional batches are expected in January. |
| 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. |
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 |
Lorazepam Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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. | West-Ward is currently experiencing a backorder situation on the Ativan and Lorazepam 2 mg/mL, 1 mL vials and also the Lorazepam 4 mg/mL, 1 mL vial.
All other presentations of Ativan and Lorazepam are available in limited quantities.
West-Ward has accelerated production on Ativan and Lorazepam 2 mg/mL, 1 mL vial codes and will have additional lots availability in the November – December 2011 timeframe. Product will be made available as it is released. |
| 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 April 2012.
Product 2 mg/mL; 1 mL Carpuject syringe (NDC 0409-1985-30): next delivery January 2012. Product 4 mg/mL; 1 mL vial (NDC 0409-6779-02): next delivery in April 2012. Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02): next delivery in April 2012.
Please note that 4 mg/mL; 1 mL Carpuject syringe (NDC 0409-1539-31) is temporarily unavailable.
Please note that 2 mg/mL; 1 mL iSecure prefilled syringe (NDC 0409-1985-05) has been discontinued.
|
| Akorn: 847-279-6100 | N/A | Akorn has Lorazepam injection available. |
Magnesium Sulfate Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 631-924-4000 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. |
| 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 January 2012. Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next delivery March 2012.
Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): next delivery January 2012.
Product 40 mg/mL-water; 100 mL bag (NDC 0409-6729-23): next delivery January 2012.
Product 40 mg/mL-water; 500 mL bag (NDC 0409-6729-03): next delivery January 2012.
Product 40 mg/mL-water; 1000 mL bag (NDC 0409-6729-09): next delivery January 2012.
Product 10 mg/mL-dextrose; 100 mL bag (NDC 0409-6727-23): next delivery January 2012.
Product 80 mg/mL-water; 50 mL bag (NDC 0409-6730-13): next delivery January 2012.
|
Mannitol Injection
(12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 250 mg/mL, 50 mL vial, 25 count | No shortage | B. Braun has increased manufacturing forecast due to an anticipated increase in demand. B. Braun has inventory of the 500 mL product and a limited inventory of the 250 mL product. B. Braun is scheduled to manufacture additional units of the 250 mL product this week with anticipated availability the second week of January 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 January 2012. Product 20%; 250 mL container (NDC 0409-7715-02): next delivery 1Q 2012. Product 20%; 500 mL container (NDC 0409-7715-03): next delivery 1Q 2012. Please check with your wholesaler for all available inventory. |
| Luitpold Pharmaceuticals, Inc. Customer Service: 1-800-645-1760 Mannitol Injection | Increase in product demand | Mannitol Injection, USP 25%, 50 mL vial on back order and the company estimates a release date of January 2012. |
Mesna 100 mg/mL Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 and 10 count product are both on allocation. |
| APP: 1-888-386-1300 10 mL vial, 1 count (NDC 63323-0773-11) 10 mL vial, 10 count (NDC 63323-0773-10) | Increased in demand | NDC 63323-0773-10 - On allocation until Mid-November and NDC 63323-0773-11 - Available for shipping. |
| 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 | Anticipating release of product Q212/Q312. |
| Baxter Customer Service: 1-800-ANA-DRUG (1-800-262-3784) 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 | Increase in demand | Several releases planned for November and December. |
Methotrexate Injection-Preservative Free (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service 1-877-946-7747 25 mg/mL; 2 mL vial 25 mg/mL; 40 mL vial; | Higher than anticipated market demand | Product 25 mg/mL; 2 mL vial (NDC 61703-350-38): next delivery January 2012.
Product 25 mg/mL; 40 mL vial (NDC 61703-408-41): next delivery January 2012. |
| Mylan Institutional 1-888-258-4199 25mg/ml; Preservative 10ml vial 40ml vial | Significant increase in demand. | Limited quantity of 2ml vials (NDC 10139-0062-02) available for emergency drop ship orders. 40ml vials (NDC 10139-0062-40) with expiration of April 2012 and May 2012 are available via drop ship orders. As additional product becomes available, it will continue to be allocated via drop ship orders. |
| Sandoz Customer Service: 1-609-627-8500 25mg/ml; Preservative Free 10ml vial 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 |
Methylphenidate HCl (updated 12/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
| 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) | Increased demand combined with unavailable raw material. | Very limited supply of most strengths of methylphenidate IR and ER tablets is available. Timing for a return to full supply is indefinite and may be extended. |
| 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 is currently out of stock of our 5 mg IR, 10 mg IR and 20 mg IR and our 20 mg ER products. UCB expects resupply by February. |
| 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 |
Metoclopramide injection (updated 10/20/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
West-Ward Pharmaceuticals Customer Service: (Formerly a Baxter Product) 5 mg/mL, 2 mL vial, 25 count (NDC 10019-0450-02) | Increased Demand | West-Ward is currently experiencing an increase in demand for metoclopramide injection 5 mg/mL, 2 mL vials (NDC 10019-0450-02). Lots are currently being manufactured and will be release for distribution as product becomes available. |
| Hospira Inc. Customer Service: 1-877-946-7747 5 mg/mL 2 mL vials (NDC 00409-3414-01) | Available | Product 5 mg/mL; 2 mL vial (NDC 0409-3414-01): ample levels of inventory to support market demand. Hospira discontinued Metoclopramide Carpuject syringes in May, 2009 and ampules in February, 2010. Please check with your wholesaler for available inventory. |
| 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) |
Mexiletine Capsules (150mg, 200mg, and 250mg) (9/24/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing Delays | Teva has mexiletine 150 mg capsules (NDC 00093-8793-01) and 250 mg capsules (NDC 00093-8741-01). There is not yet an availability date for the 200 mg capsules. |
Mitomycin Powder for Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Accord Customer Service: 919-941-7879 5 mg (NDC 16729-0115-05, 20 mg (NDC 16729-0108-11), 40 mg (NDC 16729-0116-38) | Increase in demand | Accord is releasing batches as they become available and is ramping up production to meet the increase in demand. |
| 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. |
Morphine Sulfate Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 25 mg/mL; 10 mL vial (NDC 0409-1135-02) (NDC 0409-1258-30) 2 mg/mL; 1 mL Carpuject (NDC 0409-1762-30) 0.5 mg/mL; 10 mL vial (NDC 0409-3814-12)
1 mg/mL; 10 mL vial | Manufacturing delay | Product 25 mg/mL; 10 mL vial (NDC 0409-1135-02): next delivery April 2012.
Product 4 mg/mL; 1 mL Carpuject (NDC 0409-1258-30): next delivery January 2012.
Product 2 mg/mL; 1 mL Carpuject (NDC 0409-1762-30): next delivery January 2012.
Product 0.5 mg/mL; 10 mL vial (NDC 0409-3814-12): next delivery January 2012.
Product 1 mg/mL; 10 mL vial (NDC 0409-3815-12): next delivery January 2012.
All other presentations: ample levels of inventory to support market demand.
Please check with your wholesaler for available inventory.
|
Mustargen (mechlorethamine HCl) injection (9/30/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Lundbeck Inc. Customer service number: 1-888-514-5204 | See Related Information | Lundbeck is currently working closely with FDA to gain approval of the transfer of production of Mustargen to a new manufacturing site after the company’s previous contractor discontinued commercial manufacturing of the product. Lundbeck expects Mustargen to be available again during 2011. Updates will be provided as they become available. Please see the Dear Healthcare Professional Letter (PDF - 24KB) from Lundbeck for additional information. |
Multi-Vitamin Infusion (Adult and pediatric) (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira , Inc. Customer Service 1-877-946-7747 MVI-12 Adult; 10 mL vial (NDC 61703-423-81) | Manufacturing delays | MVI Pediatric 5 mL vial (NDC 61703-421-53): next delivery December. All Adult formulations: Hospira is working to restore adequate supply. The following products are targeted for market return in 2012: -MVI-12 Adult; 2x50 mL PBP (NDC 61703-423-83)
-MVI Adult; 2x5 mL (NDC 61703-422-82)
-MVI Adult 2x50 mL PBP (NDC 61703-422-83)
|
| Baxter (Infuvite adult and pediatric IV solution) Customer Service: 1-888-229-0001 | Manufacturing delays | Infuvite is now available for Baxter. |
Nalbuphine Injection (updated 10/31/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira 1-877-946-7747 NDC and Product Description: 10 mg/mL; 10 mL vial NDC 0409-1464-01 20 mg/mL; 1 mL amp NDC 0409-1465-01 10 mg/mL; 10 mL vial NDC 0409-1467-01 | Other manufacturer shortages/market withdrawal. | Product 20 mg/mL; 1 mL amp (NDC 0409-1465-01): next delivery in March 2012.
Please check with your wholesaler for available inventory.
|
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. |
Neostigmine methylsulfate injection (updated 11/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
West-Ward Pharmaceuticals Customer Service: (Formerly a Baxter Product) 0.5 mg/mL vials (NDC 10019-0271-10), West-Ward 1 mg/mL, 10 mL vial (NDC 10019-0270-10) | Increased demand | West-Ward has available neostigmine 1 mg/mL, 10 mL vials (NDC 10019-0270-10). The 0.5 mg/mL 10 mL vials are on back order and there is not yet a reported release date. |
| American Regent/Luitpold 631-924-4000 0.5 mg/mL 10 mL vials (NDC 00517-0034-25) and 1 mg/mL 10 mL vials (NDC 00517-0033-25) | Increased demand | Additional information regarding supplies of 0.5 mg/mL 10 mL vials (NDC 00517-0034-25), 1 mg/mL 10 mL vials (NDC 00517-0033-25) will be posted as soon as it's available. |
| APP 1-888-386-1300 0.5 mg/mL, 10 mL vial (NDC 63323-0382-10), 1 mg/mL 10 mL vials (NDC 63323-0383-10) | Increased demand | APP has all Neostigmine Injection 0.5 mg/mL & 1 mg/mL presentations available. |
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). |
Norepinephrine Bitartrate Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Customer Service: 1-800-562-4797 (Bedford 4 mL vial, package of 10 (NDC 55390-0002-10)) | Manufacturing delays | Bedford has norepinephrine on back order and the company cannot estimate a release date. |
| Hospira Inc. 1-877-946-7747 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) | Available | Levophed (Norepinephrine Bitartrate Injection)
Products 1 mg/mL; 4 mL ampule (NDC 0409-1443-04) and 1 mg/mL; 4 mL vial (NDC 0409-3375-04): ample levels of inventory to support market demand.
|
| Teva Pharmaceuticals 1-800-545-8800 (Teva 4 mL vial, package of 10 (NDC 00703-1153-03)) | Teva temporarily discontinued norepinephrine in June 2010. | Teva anticipates having product available again 4th quarter 2011. |
| Sandoz Inc. | Sandoz, in conjunction with the FDA, is initiating a temporary importation of Norepinephrine Injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 296KB) for information about emergency supplies that are now available to help address the shortage. |
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/ |
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. |
Oxytocin Injection, USP (synthetic)
(12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 on back-order with an estimated release date of early to mid-February 2012.
1 mL vial available with an estimated release date of mid-January 2012
30 mL vial available. Estimated release date TBD. |
| 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) | Information pending | Information pending |
Paclitaxel Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
| 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. |
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) | Higher than anticipated market demand. | Product 300 mg/50 mL vial (NDC 0409-0342-50): next delivery January 2012.
Product 30 mg/5 mL vial (NDC 0409-0342-09): next delivery January 2012. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery February 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 expecting releases of 16.7 mL, 25 mL, and 50 mL |
| Sagent Pharmaceticals 1-866-625-1618 30mg/5mL 100mg/16.7mL 300mg/50mL | Sagent has all 3 products on allocation. |
Pancuronium Bromide Injection (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 April 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. |
Phenylephrine HCl Injection (updated 7/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| West-Ward Pharmaceuticals Customer Service: 1-888-229-0001 (Formerly a Baxter Product) 10 mg/mL, 1 mL (25s - NDC 10019-163-12) | Increase in product demand | West-Ward currently has available inventory. West-Ward has accelerated production and will have additional lots available for release in July and August. |
| Sandoz Customer Service: 1-609-627-8500 10 mg/mL, 5 mL (25s - NDC 66758-0016-04); 10 mg/mL, 10 mL (1 - NDC 66758-0017-01) | Sandoz is currently on backorder as the current market requirements are more than current inventory due to the shortage in the market. | Sandoz anticipates increased product availability by the end of July. |
| American Regent Customer Service: 1-800-645-1706 10 mg/mL, 1 mL (25s - NDC 00517-0299-25) and 10 mg/mL, 5 mL (25s - NDC 00517-0405-25) | Manufacturing delays | American Regent has available phenylephrine 10 mg/mL 1 mL (NDC 00517-0299-25) and 5 mL (NDC 00517-0405-25) vials. |
Phytonadione Injectable Emulsion (Vitamin K) (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 January 2012.
Product 10 mg/mL; 1 mL amp (NDC 0409-9158-01): November delivery received; next delivery January 2012.
Please check with your wholesaler for available inventory. |
| 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. |
Potassium Phosphate (updated 12/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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 March 2012. |
| American Regent | American Regent anticipates releasing 3 mMol/mL, 50 mL vial (NDC 00517-2350-25) vials mid-July. |
Primaquine Phosphate Tablets (updated 12/6/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sanofi-aventis U.S. LLC 1-800-633-1610 26.3 mg, 100 count (NDC 0024-1596-01) | Manufacturing issues | Sanofi-aventis U.S. is working to restore supply as soon as possible.
|
Procainamide HCL Injection (updated 11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 April 2012. 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. |
Selenium injection (10/28/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent/Luitpold: 631-924-4000 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. |
Sodium Chloride 23.4% (updated 10/20/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 30 mL vials (NDC 63323-0087-30), 100 mL vials (NDC 63323-0088-61), 200 mL vials (NDC 63323-0088-63) | 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. |
| American Regent, Inc. 1-800-645-1706 30 mL vials (NDC 00517-2930-25), 100 mL vials (NDC 00517-2900-25) | Increased demand | American Regent has sodium chloride 23.4% solution 30 mL vials and 100 mL vials are on back order and cannot estimate a release date. |
| 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.
|
Sodium Chloride 14.6% Injection (updated 10/20/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73) | Available | Products 2.5 mEq/mL; 40 mL vial (NDC 0409-6660-75) and 2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73): ample levels of inventory to support market demand. |
| APP 1-888-386-1300 14.6%, 20 mL vials (NDC 63323-0139-20), 40 mL vials (NDC 63323-0139-40) | Increased demand | APP has sodium chloride 14.6% solution for injection 40 mL vials are available. The 20 mL vials are on long-term back order with no estimated release date. |
Sodium Phosphate Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 3 mmol/mL, 15 mL vial (NDC 00409-7391-72) | Other manufacturer shortage/market withdrawal and Manufacturing delay. | Product 3 mmol/mL; 15 mL vial (NDC 0409-7391-72): next delivery in January 2012. |
| American Regent/Luitpold 631-924-4000 5 mmol/mL, 5 mL vial (NDC 00517-3405-25), 5 mmol/mL, 15 mL vial (NDC 00517-3415-25), 5 mmol/mL, 50 mL vial (NDC 00517-3450-25) | Manufacturing delays | American Regent expects mid August release for sodium phosphate 5 mmol/mL 5 mL (NDC 00517-3405-25), 15 mL (NDC 00517-3415-25), and 50 mL (NDC 00517-3450-25) vials. |
Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP) (8/5/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | 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 manufactures 5 ml vials (NDC 00703-9503-03), 10 ml vials (NDC 00703-9514-03) and 30 ml vials (NDC 00703-9526-01). Limited emergency supplies are available from Teva. |
Telavancin (Vibativ) Injection
(12/19/2011)
| 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.
|
Tetracycline Capsules (11/8/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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. |
| 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. |
Ticlopidine Tablets
(11/23/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 250 mg, 100 count (NDC 00093-0154-01) | Manufacturing delays | Teva has ticlopidine tablets on back order and the company estimates a release date in first quarter, 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 February, 2012. |
Tobramycin Solution for Injection (updated 12/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
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. |
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 mid-December 2011. |
APP 40 mg/mL, 2 mL vial (NDC 63323-0306-02)
40 mg/mL, 2 mL Novaplus vial (NDC 63323-0306-55) Tobramycin Lyophilized Powder for Injection
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51)
1.2 gram 50 mL Novaplus vial, preservative-free, 6 count (NDC 63323-0303-55) | Increase in demand/manufacturing delays | APP has tobramycin solution for injection 40 mg/mL 2 mL vials on back order and the company estimates a release date of early-December, 2011.
APP has all tobramycin 1.2 gram lyophilized powder for injection presentations on back order and the company estimates a release date of late-December, 2011. |
| 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 March 2012.
Product 40 mg/mL; 2 mL vial (NDC 0409-3578-01): next delivery March 2012.
Product 40 mg/mL; 50 mL vial (NDC 0409-3590-02): next delivery February 2012.
Please check with your wholesaler for available inventory. |
Vasopressin Injection (updated 11/15/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent/Luitpold 631-924-4000 20 units/mL Injection, 0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25), 1 mL multi-dose vial, 25 count (NDC 00517-1020-25), 10 mL multi-dose vial, 25 count (NDC 00517-0410-10) | N/A | American Regent has all strengths of vasopressin 20 units/mL injection 1 mL multi-dose vials (NDC 00517-1020-25), 10 mL multi-dose vials (NDC 00517-0410-10), 0.5 mL multi-dose vials available for ordering. |
| JHP Pitressin 20 units/mL Injection, 1 mL single-dose vial, 25 count (NDC 42023-0117-25) | N/A | Product is no longer on allocation. |
| APP 1-888-386-1300 20 units/mL Injection, 1 mL single-dose vial, 25 count (NDC 63323-0302-01) | APP has increased production to meet current demand | APP has Vasopressin 20 units/mL injection available. |
Vecuronium Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| 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 1-800-545-8800 | On manufacturing hold | Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder. |
| Hospira, Inc. Customer Service: 1-877-946-7747 10 mg vial (NDC 0409-1632-01)
20 mg vial (NDC 0409-1634-01) | Temporarily suspended . |
|
| Sagent Pharmaceticals 1-866-625-1618 10mg/vial
20mg/vial | Sagent has both the 10mg and 20mg product available. |
Vincristine Sulfate Injection (updated 12/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 1 mg/mL; 1 mL vial 1 mg/mL; 2 mL vial | Higher than anticipated market demand. | Product 1 mg/mL; 1 mL vial (NDC 61703-309-06): next delivery February.
Product 1 mg/mL; 2 mL vial (NDC 61703-309-16): ample levels of inventory to support market demand. Please check with your wholesaler for available inventory. |
| Teva Pharmaceuticals 1-800-545-8800 | Teva has 1 mg/mL 1 mL vial (NDC 00703-4402-11) and 2 mL vial (NDC 00703-4412-11) now available and is shipping to wholesalers. |
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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#oxytocin