Current Drug Shortages: Fluorouracil Injection
Wednesday, 17 August 2011 08:11
Acetylcysteine Inhalation Solution (updated 8/2/2011)
| 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): Next release in September. 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 has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date. |
Alcohol Dehydrated (Ethanol > 98%) (7/20/2011)
| 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 | American Regent anticipates releases of the 1 mL and 5mL ampoules at the end of July and August. |
Amikacin Injection (updated 7/21/2011)
| 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 amikacin 250 mg/mL 2 mL on intermittent backorder with product available as it is released. The 4 mL presentation does not have estimated estimate release timing. |
Amino Acid Injection (updated 7/14/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Hospira Customer Service All Aminosyn presentations | All Aminosyn products are available with ample levels of inventory to support recent demand. | |
| 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. |
Aminocaproic Acid
(8/11/2011)
| 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 availability is unknown at this time. Please check with your wholesaler for available inventory. |
| American Regent/Luitpold 631-924-4000 | Manufacturing delays | Lutipold estimates product being available mid-September, 2011. |
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 7/12/2011)
| 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 has improved for all dosage strengths. 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. |
Anadrol-50 tablets (Oxymetholone Tablets)
(8/1/2011)
| 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. | Please check with your wholesaler for available inventory. Meda cannot estimate a release date for additional supplies. |
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. |
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 7/26/2011)
| 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): July delivery received; next release in September. |
Buprenorphine injection (7/21/2011)
| 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 estimates a release date of 3rd quarter, 2011. |
| 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. |
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 (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. |
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 8/4/2011)
| 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 | APP has 2 gram vials available on allocation. Please see attached Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage. |
| 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) available now with next release in September. Product 20 mg/mL; 5 mL (NDC 61703-305-38) and 20 mg/mL; 25mL (NDC 61703-304-36) available now with next release in mid August. Product 100 mg/mL; 20 mL (NDC 61703-319-22): available now with next release mid August. Please check with your wholesaler for available inventory. |
Daunorubicin hydrochloride solution for injection (updated 7/21/2011)
| 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 Laboratories has limited emergency quantities of 5mg/ml solution. Cerubidine lyophilized powder for injection 20 mg is on backorder and there is not an estimate release date. |
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 7/14/2011)
| 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.. |
| 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. |
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 8/4/2011)
| 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): continuous deliveries with product currently available. Product 100 mg/mL; ADD-Vantage vial (NDC 0409-4350-03): ample levels of inventory to support market demand.
|
| 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 Liposomal (Doxil) Injection (updated 8/5/2011)
| 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 the Dear Healthcare Professional Letter (PDF - 313KB) for additional information. |
Doxorubicin Solution for Injection (updated 6/29/2011)
| 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. |
| 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 7/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford 1-800-562-4797 | Increased demand | Bedford Laboratories has all presentations on back order. The company estimates a release date by end of July for the 5 mL vials and there is not yet an estimated release date for the other presentations. |
| 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)
Fluorouracil Injection
(8/17/2011)
| 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 50mg/mL 20mL vials on intermittent back order and the company is releasing product as it becomes available. |
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 8/4/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories 1-800-562-4797 | Not currently marketed | Bedford does not have any reported date of availability. |
| 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 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 reports availability of fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25). |
Furosemide Injection (updated 7/26/2011)
| 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 | Product 10 mg/mL; 10 mL Ansyr Syringe (NDC 0409-1639-10): next release expected in August. 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 7/21/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Manufacturing delays | Bedford Laboratories has limited emergency quantities of 200mg lyophilized product (NDC 55390-0053-01). Late July is the anticipated release for the 50mg lyophilized product (NDC 55390-0051-10), 100mg lyophilized product (NDC 55390-0052-10) 350mg lyophilized product (NDC 55390-0054-10) and 500mg solution (NDC 55390-0009-01). |
| 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). |
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. |
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 |
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 8/4/2011)
| 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 available lorazepam 2 mg/mL 1 mL (NDC 10019-0102-01) and 10 mL (NDC 10019-0102-10) vials, 2 mg/mL 1 mL (NDC 10019-0105-01) and 10 mL (NDC 10019-0105-02) Novaplus vials, 4 mg/mL 10 mL (NDC 10019-0103-10) vials, and 4 mg/mL 1 mL (NDC 10019-0106-01) and 10 mL (NDC 10019-0106-02) Novaplus vials. The 4 mg/mL 1 mL vial is on back order with no estimated release date. |
| 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 September. Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02): next release in September. 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 8/4/2011)
| 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): next release in August. Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): next release in August. Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next release in September. Please check with your wholesaler for available inventory. |
Methylphenidate HCl (updated 7/26/2011)
| 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 August 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 and presentations of our methylphenidate IR and CD product.
UCB is currently out of stock of our 20 mg ER product and expect resupply by October 2011. |
| 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. |
Mitomycin Powder for Injection (6/24/2011)
| 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 anticipates release within the next six months. |
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 7/7/2011)
| 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. The following products are targeted for market return in September:
-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 (8/4/2011)
| 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 September. Hospira has all other presentations available with ample levels of inventory to support market demand. |
NeoProfen (ibuprofen lysine) Injection (updated 8/1/2011)
| 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 by end of 2011. |
Neostigmine methylsulfate injection (7/19/2011)
| 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 | Baxter 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 0.5mg/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. |
Paclitaxel Injection
(8/8/2011)
| 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: 1-877-946-7747 300 mg/50 mL vial (NDC 0409-0342-50) | Higher than anticipated market demand. | Product 300 mg/50 mL vial (NDC 0409-0342-50): next release August. Product 30 mg/5 mL vial (NDC 0409-0342-09): next release November. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next release September. Please check with your wholesaler for available inventory. |
| Bedford Laboratories 1-800-562-4797 6 mg/mL injection 30 mg/5 mL vial (NDC 55390-0114-05) | Manufacturing delays | Bedford has paclitaxel 6 mg/mL injections in 30 mg/5 mL and 100 mg/16.7 mL vials allocated for drop shipment only. The other presentations are on back order 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 currently has all paclitaxel 6 mg/mL presentations on back order. |
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. |
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. | |
| 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 7/26/2011)
| 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 | 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 7/26/2011)
| 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 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 7/29/2011)
| 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): Next delivery is expected in mid-August. |
| 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. |
Tamiflu for Oral Suspension (updated 6/30/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genentech: 1-800-551-2231 12mg/ml 25 ml (NDC 00004-0810-95) | Increased demand | Genentech plans to begin releasing Tamiflu for Oral Suspension in mid July. |
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. |
Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated 7/14/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genzyme Corporation 1-800-745-4447 | Temporary Delays | A limited supply of Thyrogen was released to the U.S. market in June. Due to unexpected delays in the release of three lots of Thyrogen, a stock-out is expected in July and will persist until these lots are released. Temporary shipment delays will then continue to occur for the remainder of 2011 and throughout 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. |
Vasopressin Injection (updated 8/1/2011)
| 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) | Manufacturing delays | APP has vasopressin 20 units/mL injection on back order and the company estimates an August release date. |
Vecuronium Injection (updated 8/4/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Increase in demand | Bedford is allocating vecuronium 20 mg vials and these are available for drop-shipment. Vecuronium 10 mg vials are on back order and no release date is reported. |
| 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) | Manufacturing delay . | Product 10 mg vial (NDC 0409-1632-01): Hospira targets return to market in 3rd quarter 2011. Product 20 mg vial (NDC 0409-1634-01): 4Q 2011. |
Vincristine Sulfate Injection (updated 7/26/2011)
| 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 currently not 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. |
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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#fluorouracil