Current Drug Shortages: Cyanocobalamin injection
Tuesday, 21 June 2011 09:40
Acetylcysteine Inhalation Solution (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 100 mg/mL; 30 mL vial (NDC 04098-3307-03) 200 mg/mL; 30 mL vial (NDC 0409-3308-03) | Higher than anticipated market demand. | Products 100 mg/mL; 30 mL vial (NDC 0409-3307-03) and 200 mg/mL; 30 mL vial (NDC 0409-3308-03): May delivery received; next release in July.
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 Labs anticipates releases in late May 2011 for acetylcysteine inhalation solution 100 mg/mL 10 mL (NDC 00054-3027-02) and 30 mL (NDC 00054-3025-02) vials and 200 mg/mL 10 mL and 30 mL 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 has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date. |
Amikacin Injection (updated 6/20/2011)
| Company | Reason | Related Information |
|---|---|---|
Teva Pharmaceuticals | Manufacturing delays | Teva has amikacin 250 mg/mL 2 mL (NDC 00703-9032-03) and 4 mL (NDC 00703-9040-03) vials on allocation. If a pharmacy cannot obtain product from their wholesaler, please have the wholesaler contact Teva directly to place an emergency order. |
| Bedford Customer Service 1-800-562-4797 | Manufacturing delays | 250 mg/mL, 2 mL vials, package of 10 (NDC 55390-0226-02) – Available in 10 pack presentation 250 mg/mL, 4 mL vials, package of 10 (NDC 55390-0226-04) – Available in 10 pack presentation |
Amino Acid Injection (updated 6/8/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Hospira Customer Service Aminosyn II 10%; 1000 mL NDC 0409-4164-05 | Commodity shortage | The next release of this product is expected in July which will achieve target inventory levels to support demand. Potential short term alternative is NDC 0409-4164-03 (Aminosyn II 10% 500mL) which has inventory available. |
| Baxter Customer Service: 1-888-229-0001 | Adequate supply is now available. | Baxter has the following bulk pharmacy Amino Acid Injections available through normal distribution. Clinisol, Baxter Prosol, Baxter Prosol 20%, 2000 mL (NDC 00338-0499-06) Travasol, Baxter |
| B Braun Customer Service 1-800-227-2862 | Increase in demand | All FreAmine 10% (S9010-SS & S9011-SS), TrophAmine 10% (S9341-SS) , and TrophAmine 6%( S9361-SS) products are off allocation and currently available to all customers via direct or indirect distribution, as inventory is very healthy to support new customers. Feel free to contact your local B. Braun sales representative or place orders via Customer Service at 800-227-2862. |
Ammonium Chloride Injection (updated 6/3/2011)
| 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: company estimates a release date of 3rd quarter, 2011.
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 6/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Shire Customer Service: 1-800-828-2088 Adderall XR capsules | API supply issues and uneven product distribution patterns. | Expect increased product availability in May 2011. Shire Customer Service Number: 1-800-828-2088 Shire Pharmacy Locator Number: 1-800-828-2088 select “Option 5” for assistance in locating a pharmacy in your area with product availability. |
| 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. |
Aquasol A, 50,000 units/mL, 2 mL ampule (NDC 61703-418-07) (12/7/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Change in manufacturing sites. | Hospira anticipates releasing product sometime in 2011. |
Arginine 10% injection (R-Gene 10) (11/30/2010)
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 6/20/2011)
| 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. The 15 unit is estimated to release mid-July and 30 unit is estimated to release early-August. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing dela | Teva has bleomycin 15 unit and 30 unit vials on back order and anticipates release by end of August 2011. |
| 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: 1-877-946-7747 15 unit vial (NDC 61703-0332-18) | Higher than anticipated market demand. | Product 15 unit vial (NDC 61703-332-18): releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct. Next delivery expected in August. Product 30 unit vial (NDC 61703-323-22): releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct. Next delivery expected in July. |
Calcitriol 1 mcg/mL Injection (updated 6/20/2011)
| 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 intermittent back order with multiple releases estimated by Late-May. |
| 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 of early August 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. |
Calcium Chloride Injection (updated 5/18/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Hospira has product available. | |
| 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 (4/1/2011)
| 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 all calcium gluconate products on intermittent back-order, due to increased demand, and the company has regular releases and distributes inventory directly to the wholesale channel. Please check with your wholesaler for all available inventory. APP has the 10mL vials (63323-311-10) and 100mL vials (63323-311-61) on back-order with estimated releases mid-March, 2011. APP has the 50mL vials (63323-311-50) also on backorder with estimated release early-April, 2011. The 200mL 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. |
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. |
Cleviprex 0.5 mg/mL 50 mL vial (NDC 65293-0002-50) 100 mL vial (NDC 65293-0002-00)(updated 6/14/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| The Medicines Company | See Related Information Section | The Medicines Company has Cleviprex 0.5mg/ml 50 ml vials (NDC 65293-0002-50) available by drop shipment through wholesalers. The 100ml vials do not yet have an availbillity date. |
Cyanocobalamin injection
(6/21/2011)
| 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 cyanocobalamin injection 1 mL and 10 mL vial sizes available. The 30 mL vial size is on backorder. |
Cytarabine Injection (updated 6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Customer Service 1-800-562-4797 100 mg vial (NDC 55390-0131-10) | Manufacturing delays | Bedford has cytarabine 1 gram vials on intermittent back order and the company is releasing product as it becomes available. All other cytarabine presentations are on back order and the company cannot estimate a release date. |
| APP 1-888-386-1300 100 mg/mL, 20 mL vial (NDC 63323-0120-20) | Manufacturing delays | Limited supplies available - please see attached Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage and estimates additional supplies to be released by end of April. |
| Hospira Inc. 1-877-946-7747 20 mg/mL; 50 mL PBP (NDC 61703-303-46), 20 mg/mL; 25 mL (NDC 61703-304-36), 20 mg/mL; 5 mL (NDC 61703-305-38), 100 mg/mL 20 mL (NDC 61703-319-22) | Higher than anticipated market demand. | Products 20mg/ml; 50 mL PBP (NDC 61703-303-46): next release in June. Product 20 mg/mL; 5 mL (NDC 61703-305-38) and 20 mg/mL; 25mL (NDC 61703-304-36): next release in July. Product 100 mg/mL; 20 mL (NDC 61703-319-22): available now with next release in June. Please check with your wholesaler for available inventory. |
Daunorubicin hydrochloride solution for injection (updated 5/10/2011)
| 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 will release 20 mg lyophilized powder for injection in early May. Bedford will release daunorubicin solution for injection, 20 mg and 50 mg, in the next 3-months. |
Desmopressin Injection (updated 6/3/2011)
| 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) | Product 4 mcg/mL; 1 mL amp (NDC 0409-2265-01): ample levels of inventory to support market demand. | |
| 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 | Sanofi is continuing to release product as soon as it becomes available. |
| 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 6/10/2011)
| 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 all dexamethasone 4mg/mL and 10mg/mL presentations on intermittent back order and the company is releasing the product as it becomes available. APP will have releases throughout June, July, and August to respond to the increased demand.. |
Digoxin Injection (updated 5/5/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 USP 250 mcg/mL, 2 mL ampuls (NDC 0641-1410-35) | Increase in product demand. | Baxter is currently experiencing a back order situation on the 2 mL ampuls (NDC 0641-1410-35). Baxter has accelerated production and will have product available by the end of April. |
| 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 6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service 1-888-229-0001 5 mL vial (NDC 10019-510-01) 10 mL vial (NDC 10019-510-02) 25 mL vial (NDC 10019-510-04) | Baxter has accelerated production due to an increase in product demand. | Baxter 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.
| Products 5 mg/mL; 5 mL (NDC 0409-1171-01) and 5 mg/mL; 10 mL vial (NDC 0409-1171-02) and 100 mg/mL; ADD-Vantage vial (NDC 0409-4350-03): continuous deliveries with product currently available. Please check with your wholesaler for available inventory. |
| 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 anticipates release of all presentations in the next 3 months. |
Doxorubicin (adriamycin) lyophilized powder (updated 5/10/2011)
| 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 anticipates release of all presentations in the next 6-months. |
Doxorubicin Solution for Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 APP Product Availability Information | Increased demand | APP is releasing the 2mg/ml 100 ml vials (NDC 63323-0101-61), the 2mg/ml 25 ml vials (NDC 63323-0883-30), and the 2mg/ml 5 ml vials (NDC 63323-0883-05) as it becomes available. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva is releasing all strengths on allocation: 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). |
| Bedford 1-800-562-4797 | Manufacturing delays | Bedford anticipates release of the 50mg presentation in the next 3months and release of the 10 mg, 25 mg, and 100 mg solutions in the next 6-months. |
Erythromycin lactobionate injection (6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Hospira Inc. 500 mg vial | Both presentations: ample levels of inventory to support market demand. |
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 6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford 1-800-562-4797 | Increased demand | Bedford estimates releasing the 5ml vials (NDC 55390-0291-01) at the end of June and the 25ml vials (NDC 55390-0292-01) mid-June, 2011. No estimated date of availability for the 50ml vials (NDC 55390-0293-01). |
| 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) (3/25/2011)
Foscarnet Sodium Injection (updated 6/3/2011)
| 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 letter for information about availability from Clinigen in the UK (PDF - 1.8MB) |
Fosphenytoin Sodium Injection (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories 1-800-562-4797 | Not currently marketed | Bedford will be off the market for an undefined period of time. |
| Hospira Customer Service: 1-877-946-7747 75 mg/mL; 2 mL vial 75 mg/mL; 50 mL vial | Manufacturing delay | Hospira is working to restore adequate supply, however, no timing is available. |
| Akorn Pharmaceuticals 1-800-932-5676 | Not currently marketed | Akorn will be off the market for an undefined period of time. |
| APP 1-888-386-1300 | Increase in demand | APP continues to release product as it becomes 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 has available fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25). |
Furosemide Injection (updated 6/16/2011)
| 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 | Products 10 mg/mL; 4 mL Ansyr syringe (NDC 0409-9631-04) , 10 mg/mL; 10 mL Ansyr Syringe (NDC 0409-1639-10): next release in 3rd Quarter 2011. All other presentations: ample levels of inventory to support market demand. Please check with your wholesaler for available inventory. |
| 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 5/10/2011)
| 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 haloperidol decanoate available in 50 mg/mL 5 mL vials (NDC 63323-0469-05). 100 mg/mL 5 mL vials (NDC 63323-0471-05) and 100 mg/mL 1mL vials (NDC 63323-0471-01) and 50 mg/mL 1 mL vials (NDC 63323-0469-01) are being released as they become available. |
| Bedford Laboratories Customer Service 1-800-562-4797 | Product discontinued | Bedford has all presentations of the Haloperidol Decanoate discontinued. |
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) |
Leucovorin Calcium Lyophilized Powder for Injection (updated 6/20/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Manufacturing delays | Bedford anticipates releasing the 50mg lyophilized product ((NDC 55390-0051-10) at the end of July and the 100mg lyophilized product (NDC 55390-0052-10) ) mid-June, 2011. The 200mg (NDC 55390-0053-01) and 350mg lyophilized product (NDC 55390-0054-10) will be released mid June, 2011. The 500mg solution (NDC 55390-0009-01) will be released at the end of July, 2011. |
| 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 | APP has recently launched their leucovorin injection in response to the ongoing shortage. | APP is currently back-ordered. Initial supplies are limited, however APP is continuing to produce and release leucovorin calcium lyophilized powder for injection (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV). |
Levoleucovorin (Fusilev) 50 mg single use vials (updated 5/24/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Spectrum Pharmaceuticals 1-877-387-4538 or 1-877-FUSILEV | Spectrum Pharmaceuticals has increased production of Fusilev 50 mg vials (NDC 68152-101-00) and is continuing to release supplies as they become available. 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 |
Levorphanol 2mg Tablets (6/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Roxane Laboratories 1-614-276-4000 | Indefinitely Discontinued | Product currently unavailable |
Lorazepam Injection(updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 2 mg/mL, 1 mL vial (NDC 10019-0102-01), 1 mL Novaplus vial (NDC 10019-0105-01), 10 mL vial (NDC 10019-0102-10) | Baxter has accelerated production due to an increase in product demand. | Baxter has lorazepam 2 mg/mL, 10 mL vials (NDC 10019-0102-10) currently available for distribution. The 2 mg/mL, 1 mL vial presentation (NDC 10019-0102-01) will be on back order until the end of April. |
| 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. | Bedford has all lorazepam injection presentations on long-term back order and the company cannot estimate a release date. |
Hospira Inc. Customer Service: 2 mg/mL; 1 mL vial | Higher than anticipated market demand. | Products 2 mg/mL; 1 mL vial (NDC 0409-6778-02), 2 mg/mL; 10 mL vial (NDC 0409-6780-02) and 2 mg/mL; 1 mL Carpuject syringe (NDC 0409-1985-30): ample levels of inventory to support market demand. Product 4 mg/mL; 1 mL vial (NDC 0409-6779-02): next release in June. Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02): next release in July. Please note that 2 mg/mL; 1 mL iSecure prefilled syringe (NDC 0409-1985-05) and 4 mg/mL; 1 mL Carpuject syringes (NDC 0409-1539-31) are temporarily unavailable. Please check with your wholesaler for available inventory. |
| Akorn: 847-279-6100 | N/A | Akorn has Lorazepam injection available. |
Magnesium Sulfate Injection (updated 6/16/2011)
| 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 550%; 20 mL vial (NDC 0409-2168-02) 40 mg/mL; 50 mL bag (NDC 0409-6729-24), 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10) | Higher than anticipated market demand. | Product 50%; 20 mL vial (NDC 0409-2168-02): May delivery received; next release in June. Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): next release in June. Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next release in August. Please check with your wholesaler for available inventory. |
Methylphenidate HCl (updated 6/7/2011)
| 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) | This shortage is due to Active Pharmaceutical Ingredient (API) constraints. | Mallinckrodt expects to have continued gradual improvement over the next two months, with full recovery by July 2011. |
| 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 in stock in all strengths of our methylphenidate products (IR, ER, and CD) and presentations. |
| 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 | Continues to have product available. |
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 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: (1-888-229-0001) 5 mg/mL, 2 mL vial, 25 count (NDC 10019-0450-02) | Increased Demand | Baxter 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) | 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. |
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 6/3/2011)
| 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): ample levels of inventory to support market demand. All Adult formulations: Hospira is working to restore adequate supply, however, no timing is available. |
| Baxter (Infuvite adult and pediatric IV solution) Customer Service: 1-888-229-0001 | Manufacturing delays | Infuvite is now available for Baxter. |
Nalbuphine Injection (6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira 1-877-946-7747 NDC and Product Description: 10 mg/mL; 1 mL Novaplus amp NDC 0409-1463-49 10 mg/mL; 10 mL vial NDC 0409-1464-01 20 mg/mL; 1 mL amp NDC 0409-1465-01 20 mg/mL; 1 mL Novaplus amp NDC 0409-1465-49 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 release in July. Product 20 mg/mL; 1 mL Novaplus amp (NDC 0409-1465-49): available with limited supply. Hospira has all other presentations available with ample levels of inventory to support market demand. Please check with your wholesaler for available inventory. |
NeoProfen (ibuprofen lysine) Injection (9/8/2010)
| 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 mid-2011. |
Neostigmine methylsulfate injection (6/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: (1-888-229-0001) 0.5 mg/mL vials (NDC 10019-0271-10), Baxter 1 mg/mL, 10 mL vial (NDC 10019-0270-10) | Increased demand | Both strengths are on backorder with anticipation to have additional supply available in the March-April timeframe. |
| 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 0.5mg/mL and 1mg/mL presentations on allocation due to increased demand. |
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 6/1/2011)
| 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 anticipates release in the next 3-months. |
| Hospira Inc. 1-877-946-7747 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) | Higher than anticipated market demand. | Levophed (Norepinephrine Bitartrate Injection) 1 mg/mL; 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) are currently available with continuous deliveries going forward; ample levels of inventory to support market demand are expected by the end of third quarter. Please check with your wholesaler for available inventory.
|
| 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. |
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. |
Oxsoralen-Ultra (methoxsalen) 10 mg capsules (6/17/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Valeant Pharmaceuticals International Customer Service 1-800-556-1937 | Manufacturing delays | Valeant has released limited quantity of Oxsoralen-Ultra 10mg capsules to the market and is committed to ensuring the product is allocated properly to patients in need. Please see the Dear Healthcare Professional Letter (PDF - 49KB) for additional information. You may also contact Valeant by e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it for additional information. |
Pentosan Polysulfate sodium 100mg capsules
(5/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Ortho Woman’s Health & Urology ELMIRON (Pentosan Polysulfate sodium) 100mg capsules | Manufacturing delays | Ortho Women’s Health is in backorder for ELMIRON (Pentosan Polysulfate sodium) 100mg capsules. Current estimate on resupply is 2 to 3 months. Any questions from consumers and/or Health Care Providers should be directed to the Customer Call Center 1-800-526-7736. |
Phenylephrine HCl Injection (4/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 10 mg/mL, 1 mL (25s - NDC 10019-163-12) | Increase in product demand | Baxter is currently experiencing a back order situation on the 1 mL vial (NDC 10019-163-12) Baxter has accelerated production and will have product available in mid May. Additional lots are scheduled for manufacturing and will be available for distribution in the June – July timeframe. |
| 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 May. |
| 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 cannot estimate a release date at this time. |
Potassium Phosphate (updated 6/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. (1-877-946-7747) | Hospira, in agreement with FDA, will return to manufacturing Potassium Phosphate Injection to address the critical shortage so that patient needs continue to be met. Hospira understands the critical necessity of this molecule to the healthcare community and is quickly assessing manufacturing re-start timing and anticipated market recovery dates. At this time an ETA is unavailable. | |
| American Regent | American Regent anticipates releasing 3 mMol/mL, 50 mL vial (NDC 00517-2350-25) vials mid-July. |
Procainamide HCL Injection (updated 6/3/2011)
| 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): ample levels of inventory to support market demand.
Product 100 mg/mL; 10 mL vial (NDC 0409-1902-01): next release June.
Please check with your wholesaler for available inventory. |
Propofol Injection (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Teva Pharmaceuticals has discontinued their propofol injection. | Questions and Answers on the Propofol Shortage |
| Hospira Inc. Customer Service
| Higher than anticipated market demand. | Products 10 mg/mL; 20 mL (0409-4699-30), 10 mg/mL; 50 mL (0409-4699-33) and 10 mg/mL; 100 mL (0409-4699-24): frequent releases. Please check with your wholesaler for available inventory. |
| APP 1--888-386-1300 | APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section | APP has available ALL generic Propofol 1% sizes (20mL, 50mL and 100mL) and generic Novaplus propofol (20 mL, 50mL and 100 mL) vials available through wholesalers and distributors. Effective May 19, 2011 orders should be placed directly with wholesalers and distribution centers. See http://www.apppharma.com/our-products/product-updates.html for more information. APP Diprivan (20mL, 50mL and 100mL) and Novaplus Diprivan (20mL, 50mL, and 100 mL) vials are on intermittent back order and the company is releasing product weekly. These presentations can be ordered direct through APP, or wholesalers can place drop ship orders on the customer's behalf directly with APP. |
Sodium Chloride 23.4% (updated 6/10/2011)
| 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 30 mL and 100 mL vials on allocation. The 200 mL vials are on back order and the company estimates a release date of early-April, 2011. |
| 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 | Products 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02) and 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02): expected to be available in late 2011. |
Sodium Chloride 14.6% Injection (updated 6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73) | Higher than anticipated market demand. | 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 with next release in June. |
| APP 1-888-386-1300 14.6%, 20 mL vials (NDC 63323-0139-20), 40 mL vials (NDC 63323-0139-40) | Increased demand | APP does not yet have a release date. |
Sodium Phosphate Injection (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 3 mmol/mL, 15 mL vial (NDC 00409-7391-72) | Manufacturing delay | Product 3 mmol/mL; 15 mL vial (NDC 0409-7391-72): company estimates next release in 3rd Quarter 2011. |
| 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 has sodium phosphate injections on back order and the company cannot estimate a release date. |
Succinylcholine injection (5/27/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sandoz 1-800-525-8747 | Increased demand | Sandoz reports weekly releases are occurring for Anectine 20 mg/mL 10 mL vials (NDC 00781-3009-95) |
Hospira All presentations. | Hospira has all presentations available with ample levels of inventory to support market demand. |
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. |
Tamiflu for Oral Suspension 12mg/ml 25 ml (NDC 00004-0810-95) (1/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genentech: Product support and fulfillment: 1-800-551-2231 For medical information: 1-800-821-8590 | Increased demand | Genentech has Tamiflu for Oral Suspension on backorder, however supplies remain in distribution at wholesalers and pharmacies. Tamiflu 75mg, 45 mg and 30 mg capsules remain available. For those patients who have difficulty swallowing capsules, the contents can be mixed into sweetened liquids, such as chocolate syrup, as directed by a healthcare professional. If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available. Please refer to the Tamiflu package insert for information regarding compounding an oral suspension from Tamiflu 75mg capsules or see the following link for healthcare professionals: Tamiflu |
Thiotepa for Injection (updated 6/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 15 mg/mL vial (NDC 55390-0030-10) | Manufacturing delays | Bedford anticipates release within the next three months. |
| 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. |
Thyroid (desiccated) tablets (2/12/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Forest RLC | Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. | FDA approved levothyroxine products continue to be available from multiple manufacturers. |
Thyrolar Tablets (12/31/2009)
| Company/Products | Reason | Related Information |
|---|---|---|
| Forest Pharmaceuticals | Manufacturing delays | Forest has not yet reported when Thyrolar will be available. |
Tromethamine (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 500 mL (NDC 0409-1593-04) | Product 500 mL (NDC 0409-1593-04): ample levels of inventory to support market demand. |
Vasopressin Injection
(6/2/2011)
| 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 | JHP has Pitressin on allocation. |
| APP 1-888-386-1300 20 units/mL Injection, 1 mL single-dose vial, 25 count (NDC 63323-0302-01) | Manufacturing delays | APP has vasopressin 20 units/mL injection on back order and the company estimates an August release date. |
Vecuronium Injection (updated 6/3/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Increase in demand | Bedford anticipates release of the 10mg product in early May and the 20mg product in the next 3-months. |
| 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) | Manufacturing delay . | Hospira will be off-market for an undefined period. |
Vincristine Sulfate Injection (updated 6/16/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. Customer Service: 1-877-946-7747 1 mg/mL; 1 mL vial (NDC 61703-309-06) (NDC 61703-309-16) | Higher than anticipated market demand. | Product 1 mg/mL; 1 mL vial (NDC 61703-309-06): ample levels of inventory to support market demand. Product 1 mg/mL; 2 mL vial (NDC 61703-309-16): product available; next release in August. 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. |
Xeloda 500 Tablets (3/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genentech 1-800-GENENTECH | Recall of 13 manufacturing lots of the customary 120 count bottles currently approved for use in the US. Genentech is working closely with FDA to ensure that US supply of Xeloda 500mg tablets remains unchanged. | Please see the Dear Healthcare Professional Letter (PDF - 95KB). |
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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#cyanocobalamin