Current Drug Shortages: Sodium Acetate Injection (updated)
Tuesday, 14 August 2012 10:09
*Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012
Secretin Injection (ChiRhoStim) (Initial posting-6/15/12)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| ChiRhoClin Customer service- 1-877-272-4888 | 16 mcg vial (NDC 67066-2225-01) | No presentations are available. | On back order and the company cannot estimate a release date. Shortage per Manufacturer: | Other |
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| American Regent/Luitpold 1-800-645-1706 | 40 mcg/mL elemental selenium | Available | Please check with your wholesaler for available inventory. | Revised 8/8/2012 |
Sodium Acetate Injection (Initial Posting Date) - 1/31/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| APP 1-888-386-1300 | 2 mEq/mL, 100 mL vial (NDC 63323-0032-61) | Currently back-ordered | APP has sodium acetate on back order and expects a release mid August. Shortage per Manufacturer: | Demand increase for the drug. | Revised 7/31/2012 |
American Regent, Inc./Luitpold | 2 mEq/mL, 20 mL vial (NDC 00517-2096-25) | Unavailable | Shortage per Manufacturer: Increased Demand American Regent is currently not releasing the 20 mL or 50mL vials. | Discontinuation of the manufacture of the drug. | Reverifiedd 8/8/2012 |
| 2 mEq/mL, 100 mL vial (NDC 00517-2500-25) | Discontinued | ||||
| 4 mEq/mL, 50 mL vial (NDC 00517-5023-25) | Unavailable | ||||
| Hospira Inc. Customer Service 1-877-946-7747 | 2 mEq/mL; 20 mL vial (NDC 0409-7299-73) | Next delivery August | Please check with your wholesaler for available inventory. | Other manufacturer shortage/market withdrawal. | Revised 7/30/2012 |
| 2 mEq/mL; 50 mL vial (NDC 0409-3299-05) | Ample levels of inventory available to meet market demand | ||||
| 2 mEq/mL; 100 mL vial (NDC 0409-3299-06) | Next delivery August |
Sodium Bicarbonate Injection (Initial Posting-3/20/12)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Amphastar Pharmaceuticals Inc. Customer Service: 1-800-423-4136 | 8.4%, 50mL Luer-Jet Prefilled Syringe
NDC 76329-3352-1 (old NDC 0548-3352-00) | Amphastar will regularly release products. | Amphastar is experiencing a product shortage due to an increase in product demand caused by market supply issues. Shortage per Manufacturer: | Demand increase for the drug. | Reverified 7/23/2012 |
APP | 4.2% 2.5 mEq, 5 mL (NDC 63323-0026-05) | APP is currently back-ordered and expects a release early September. | Please check wholesalers for inventory. Shortage per Manufacturer: | Demand increase for the drug. | Revised 7/31/2012 |
| Hospira, Inc. Customer Service: 1-877-946-7747 | 4%; 5 mL vial (NDC 0409-6609-02) | Next delivery July | Please check with your wholesaler for available inventory. | Other Manufacturer Shortages/Market Withdrawal | Revised 7/30/2012 |
| 0.5 mEq/mL; 10 mL Abboject (NDC 0409-5534-34) | Ample levels of inventory to support market demand | ||||
| 0.9 mEq/mL; 50 mL Abboject (NDC 0409-4916-34) | Next delivery August | ||||
| 1 mEq/mL; 50 mL vial (NDC 0409-6625-02) | Next delivery August | ||||
| 1 mEq/mL; 50 mL Abboject (NDC 0409-6637-34) | Next delivery August | ||||
| 1 mEq/mL; 10 mL Abboject (NDC 0409-4900-34) | Next delivery August |
Sodium Chloride 0.9% (5.8mL and 20mL) (Initial Posting Date) – 5/4/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Lantheus Medical Imaging 1-800-299-3431 | 5.8 mL, pack of 6 vials (NDC 11994-512-05) with Technetium Tc99m Generator | Lantheus has Sodium Chloride 0.9% (5.8mL and 20mL) on back order and cannot estimate a release date. | Commercially available Sodium Chloride has inconsistent inventory availability. Shortage per Manufacturer: | Other | Reverified 7/24/2012 |
| 20 mL, pack of 6 vials (NDC 11994-512-20) with Technetium Tc99m Generator |
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| APP 1-888-386-1300 | 30 mL vials (NDC 63323-0087-30) | Check Wholesalers for Inventory. | APP has all presentations of sodium chloride 23.4% solution for injection on intermittent back order and the company is releasing product as it becomes available. Shortage per Manufacturer:
| Demand increase for the drug. | Reverified 7/31/2012 |
| 100 mL vials (NDC 63323-0088-61) | |||||
| 200 mL vials (NDC 63323-0088-63) | |||||
| American Regent/Luitpold 1-800-645-1706 | 30 mL vials (NDC 00517-2930-25) | Unavailable | American Regent/Luitpold is no longer manufacturing Sodium Chloride Injection 23.4%.. | Discontinuation of the manufacture of the drug. | Reverified 8/8/2012 |
| 100 mL vials (NDC 00517-2900-25) | |||||
| Hospira Inc. Customer Service: 1-877-946-7747 | 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02) | Expected availability is TBD. | Shortage per Manufacturer: | Other | Reverified 7/30/2012 |
| 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02) | Expected availability is TBD. |
Sodium Lactate Injection (Initial Posting Date – 5/17/2012)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Hospira, Inc. Customer Service 1-877-946-7747 | 5 mEq/mL; 10 mL, 25s(NDC 0409-6664-02) | Next delivery July | Please check with your wholesaler for available inventory. Shortage per Manufacturer: | Other | Reverified 7/30/2012 |
| Baxter Customer Service 1-800-262-3784 | 167 mEq/mL; 1000 mL (NDC 00338-0129-04) | Baxter has discontinued manufacturing of the product. | Shortage per Manufacturer: Product has been discontinued | Discontinuation of the manufacture of the drug. | 5/17/2012 |
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Akorn: 1-800-932-5676 | 50 mcg/mL, 1 mL ampoule, 10 pack NDC 17478-0050-01 | Available in wholesalers, releasing in August | Quota request filed. (Per manufacturer) Shortage per Manufacturer: | Other | Revised 7/12/2012 |
50 mcg/mL, 2 mL ampoule, 10 pack NDC 17478-0050-02 | Available in wholesalers, releasing in July | ||||
| 50mcg/ml, 5ml ampule, 10 pack NDC 7478-0050-05 | Available in wholesalers, releasing in August | ||||
Hospira, Inc. | Sufentanil 50 mcg/mL 1 mL ampule (NDC 0409-3380-31) | Next delivery 2Q 2013 | Please check with your wholesaler for all available inventory. Shortage per Manufacturer: | Other | Reverified 7/30/2012 |
Sufentanil 50 mcg/mL 1 mL vial (NDC 0409-3382-21) | |||||
Sufentanil 50 mcg/mL 2 mL ampule (NDC 0409-3380-32) | |||||
Sufentanil 50 mcg/mL 2 mL vial (NDC 0409-3382-22) | |||||
Sufentanil 50 mcg/mL 5 mL ampule (NDC 0409-3380-35) | |||||
| Sufentanil 50 mcg/mL 5 mL vial (NDC 0409-3382-25) | |||||
| West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 | 50 mcg/mL, 1 mL ampul | West-Ward is currently experiencing a backorder situation on all presentations. Multiple lots of each code are scheduled for production and anticipated to be available at the end July or beginning of August 2012. | West-Ward has accelerated production. Product will be made available as it is released. Shortage per Manufacturer: Increase in product demand. | Demand increase for the drug. | Revised 7/9/2012 |
50 mcg/mL, 2 mL ampul (NDC 0641-6111-10) | |||||
50 mcg/mL, 5 mL ampul (NDC 0641-6112-10) |
Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
Teva Pharmaceuticals | 80 mg/16 mg/mL, 5 mL (NDC 00703-9503-03) | Teva is reviewing orders for the 5mL and 10mL presentations prior to distribution. | Shortage per Manufacturer: Manufacturing Delays | Other | Reverified 7/25/2012 |
| 80 mg/16 mg/mL, 10 mL (NDC 00703-9514-03) | |||||
| 80 mg/16 mg/mL, 30 mL (NDC 00703-9526-01 | The 30 mL is on back order and Teva estimates a release date of Jan 2013. | ||||
Telavancin (Vibativ) Injection (updated 1/6/2012)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Astellas Pharma US, Inc. 1-800-727-7003 | PDS 750 mg (NDC 00469-3575-50) | Astellas has no estimated date of availability. | See the Dear Health Care Provider Letter (PDF - 142KB) Shortage per Manufacturer:
| Other | 1/6/2012 |
| PDS 250 mg (NDC 00469-3525-30) |
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Teva Pharmaceuticals 1-888-838-2872 | 250 mg, 100 count (NDC 00172-2416-60) | Temporarily unavailable | Teva has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date. Shortage per Manufacturer: | Other | Reverified 6/29/2012 |
| 250 mg, 100 count unit dose (NDC 00172-2416-10) | Temporarily unavailable | ||||
| 250 mg, 1000 count (NDC 00172-2416-80) | Temporarily unavailable | ||||
| 500 mg, 100 count (NDC 00172-2407-60) | Temporarily unavailable | ||||
| 500 mg, 100 count unit dose (00172-2407-10) | Temporarily unavailable | ||||
| 500 mg, 1000 count (NDC 00172-2407-80) | Temporarily unavailable | ||||
| Watson Customer Service: (973) 355-8300 | 250 mg, 100 count (NDC 00591-2234-01) | Watson has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date. Shortage per Manufacturer: | Other | Reverified 5/17/2012 | |
| 250 mg, 1000 count (NDC 00591-2234-10) | |||||
| 500 mg, 100 count (NDC 00591-2235-01) | |||||
| 500 mg, 1000 count (NDC 00591-2235-10) |
Thiotepa for Injection (updated 12/2/2011)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | 15 mg/mL vial (NDC 55390-0030-10) | Bedford Laboratories has 15mg available in limited quantities. Once this supply is depleted, the next estimated release dates are unknown. | Availability of products is updated on the Bedford Laboratories website. Shortage per Manufacturer: | Discontinuation of the manufacture of the drug. | Revised 4/10/2012 |
| Adienne | Please see the Dear Healthcare Professional Letter (PDF - 68KB) for information about emergency supplies that are now available to help address the shortage. | Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. | Other | Revised 7/19/2012 |
Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated 11/22/2011)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Genzyme Corporation 1-800-745-4447 | 1.1 mg vials, kit with 2 vials Thyrogen and 2 vials diluent (NDC 58468-1849-04) | Intermittent shipments of the product have resumed globally. Genzyme continues to expect that Thyrogen supply constraints will occur through 2012. | Shortage per Manufacturer: Temporary Delays | Other | 11/22/2011 |
Thyrolar Tablets (12/31/2009)
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Forest Pharmaceuticals 1-800-678-1605 | Forest has not yet reported when Thyrolar will be available. | Shortage per Manufacturer: Manufacturing delays | Other |
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | 250 mg, 100 count (NDC 00093-0154-01) | Available. Teva supply adequate to meet demand. | N/A | Revised 7/18/2012 | |
| Apotex Corporation Customer Service: 1-(877)-4-Apotex | Ticlopidine Tablets 250 mg, 30 count (NDC 60505-0027-02) | Tentative release revised to late August 2012. | Shortage per Manufacturer: This product is on back order. | Other | Reverified 7/25/2012 |
| Ticlopidine Tablets 250 mg, 60 count (NDC 60505-0027-04) | |||||
| Ticlopidine Tablets 250 mg, 500 count (NDC 60505-0027-07) | |||||
Tobramycin Solution for Injection
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
Teva Pharmaceuticals | 40 mg/mL, 2 mL vial (NDC 00703-9402-04) | All tobramycin 40 mg/mL solution for injection on long term back order and the company cannot estimate a release date. | Shortage per Manufacturer: | Other | Reverified |
40 mg/mL, 30 mL vial (NDC 00703-9416-01) | |||||
Pfizer
| 40 mg/mL, 2 mL vial (NDC 00069-0088-02) | The 2mL vial is expected to be available in mid August. | Shortage per Manufacturer: | Other | Reverified |
40 mg/mL, 30 mL vial (NDC 00069-0091-03) | Available | ||||
APP 1-888-386-1300 | 10 mg/ml; 2ml vial (NDC 63323-0305-02) | Available | All presentations currently available. Please check wholesalers for inventory. Shortage per Manufacturer: | Demand increase for the drug. | Revised 7/31/2012 |
40 mg/mL, 2 mL vial (NDC 63323-0306-02) | |||||
40 mg/mL, 30 mL vial (NDC 63323-0306-30) | |||||
40 mg/mL, 50 mL vial (NDC 63323-0307-51) | |||||
40 mg/mL, 2 mL Novaplus vial (NDC 63323-0306-55) | |||||
40 mg/mL, 30 mL Novaplus vial (NDC 63323-0306-56) | |||||
Tobramycin Lyophilized Powder for Injection | |||||
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51) | |||||
1.2 gram 50 mL Novaplus vial, preservative-free, 6 count (NDC 63323-0303-55) | |||||
Hospira, Inc. | 80 mg/mL in 0.9% NaCl; 100 mL (NDC 0409-3470-23) | Next delivery December | Please check with your wholesaler for available inventory. Shortage per Manufacturer:
| Demand increase for the drug. | Reverified |
10 mg/mL; 2 mL vial | Next delivery 1Q 2013 | ||||
40 mg/mL; 2 mL vial | Next delivery 1Q 2013 | ||||
40 mg/mL; 50 mL vial | Next delivery 1Q 2013 |
Tromethamine Injection (Initial Posting Date) - 5/2/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| Hospira, Inc. Customer Service: 1-877-946-7747 | 0.3 M; 500 mL bottle (NDC 0409-1593-04) | Next delivery August | Please check with your wholesaler for available inventory. Shortage per Manufacturer: | Other | Reverified 7/30/2012 |
Viaspan Cold Storage Solution 1000 mL Bag (Initial Posting Date) - 4/16/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
Distributed Under the Barr/Duramed Pharmaceuticals Label. Barr & Duramed are Affiliates of Teva Pharmaceuticals USA Teva Pharmaceutical | 1000 mL bag | Available with ample inventory. | Comments:
Contact information for this issue: | Product Recall of two (2) batches | Revised 7/25/2012 |
Vinblastine Sulfate Injection (Initial Posting Date) - 1/31/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| APP 1-888-386-1300 | 1 mg/mL; 10 mL vial (NDC 63323-0278-10) | Available | Check wholesalers for inventory. Shortage per Manufacturer: | Demand increase for the drug. | Reverified 7/31/2012 |
Zinc Injection (Initial Posting Date)- 2/15/2012
| Company | Product | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per New Legislation-FDASIA)* | Date Updated |
|---|---|---|---|---|---|
| American Regent/Luitpold 1-800-645-1706 | 1 mg/mL, 10 mL vial, package of 25 (NDC 00517-6110-25) | Unavailable | American Regent is currently not releasing the 5 mL (concentrate) or the 10 mL vial sizes. | Revised 8/8/2012 | |
| 5 mg/mL Concentrate, 5 mL vial, package of 25 (NDC 00517-8105-25) | |||||
| Unavailable | |||||
| Hospira, Inc. Customer Service: 1-877-946-7747 | 1 mg/mL, 10 mL vial (NDC 0409-4090-01) | Next delivery December | Please check with your wholesaler for all available inventory. Shortage per Manufacturer: | Demand increase for the drug. | Reverified 7/30/2012 |
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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314743.htm#sodiuma