FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Piperacillin and Tazobactam (Zosyn) Injection
Status: Currently in Shortage
»Date first posted: 04/02/2014
»Therapeutic Categories: Anti-Infective; Pediatric

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Apollo Pharmaceuticals Inc. (New 03/17/2017)

Company Contact Information:
800-881-3550

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
3.375 gm/vial (Vial) (NDC 39822-0125-3) Available Available under X-GEN Pharmaceuticals, Inc. To order, contact X-GEN Pharmaceuticals, Inc. Customer Service/Order Entry at 1-866-390-4411. Other
3.375 gm/vial (Carton of 10) (NDC 39822-0125-4) Available Available under X-GEN Pharmaceuticals, Inc. To order, contact X-GEN Pharmaceuticals, Inc. Customer Service/Order Entry at 1-866-390-4411. Other

Apotex Corp. (Revised 03/16/2017)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 gm/vial (10 Vials) (NDC 60505-0686-4) Available Demand increase in the drug
3.75 gm/vial (10 Vials) (NDC 60505-0687-4) Available Demand increase in the drug
4.5 gm/vial (10 Vials) (NDC 60505-0688-4) On backorder. Estimated Recovery: June 2017 Demand increase in the drug
40.5 gm/vial (NDC 60505-0773-4) Available Demand increase in the drug

Aurobindo Pharma (Revised 01/20/2015)

Company Contact Information:
732-839-9400

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g SDV Cartons of 10 (NDC 55150-119-30) On intermittent back order; the company is releasing product as it becomes available. Check whole-salers for inventory. Other
3.375 g SDV Cartons of 10 (NDC 55150-120-30) On intermittent back order; the company is releasing product as it becomes available. Check whole-salers for inventory. Other
4.5 g SDV Cartons of 10 (NDC 55150-121-50) On intermittent back order; the company is releasing product as it becomes available. Check whole-salers for inventory. Other

Fresenius Kabi USA, LLC (Reverified 03/24/2017)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g, single-dose vial (NDC 63323-309-20) Currently backordered. Increasing manufacturing and shipping upon release. Check wholesalers for inventory. Demand increase for the drug
3.375 g, single-dose vial (NDC 63323-300-30) Currently backordered. Increasing manufacturing and shipping upon release. Check wholesalers for inventory. Demand increase for the drug
4.5 g, single-dose vial (NDC 63323-320-50) Currently backordered. Increasing manufacturing and shipping upon release. Check wholesalers for inventory. Demand increase for the drug
40.5 g, PBP (NDC 63323-304-74) Currently backordered. Increasing manufacturing and shipping upon release. Check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 03/27/2017)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g Add-Vantage Vial (NDC 0409-3374-02) Next delivery: Late April 2017; Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other
3.375 g; Add-Vantage Vial (NDC 0409-3378-13) Next delivery: Late May 2017; Estimated recovery: 2Q 2017 Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other
4.5 g; Add-Vantage Vial (NDC 0409-3379-04) Next delivery: Late May 2017; Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other
2.25 g; Vial (NDC 0409-3383-02) Next delivery: Late May 2017; Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other
3.375 g; Vial (NDC 0409-3385-13) Next delivery: Late May 2017; Estimated recovery: 2Q 2017 Limited Supply. Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other
4.5 g; Vial (NDC 0409-3390-04) Next delivery: Late March 2017; Estimated recovery: 2Q 2017 Please check with your wholesaler for available inventory. Shortage per manufacturer: Manufacturing Delay. Other

Mylan Institutional (Reverified 03/28/2017)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
3.375 g Pkg of 10 (NDC 67457-522-37) Available Demand increase for the drug
4.5 g Pkg of 10 (NDC 67457-523-45) Available Demand increase for the drug
2.25g Pkg of 10 (NDC 67457-521-22) Available Demand increase for the drug

Pfizer Pharmaceuticals (Reverified 03/27/2017)

Company Contact Information:
800-533-4535

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Zosyn 2.25/50mL Frozen Bag 24's (NDC 0206-8860-02) Available Available Other
Zosyn 3.375/50mL Frozen Bags 24's (NDC 0206-8861-02) Available Available Other
Zosyn 4.5/100mL Frozen Bags 12's (NDC 0206-8862-02) Available Available Other
Zosyn 2.25g 10's (NDC 0206-8852-16) Unavailable Next delivery and estimated recovery TBD Manufacturing Delays
Zosyn 3.375g 10's (NDC 0206-8854-16) Unavailable Next delivery and estimated recovery TBD Manufacturing Delays
Zosyn 4.5g 10's (NDC 0206-8855-16) Unavailable Next delivery and estimated recovery TBD Manufacturing Delays
Zosyn 40.5g Pharm Bulk 1's (NDC 0206-8859-10) Unavailable Next delivery and estimated recovery TBD Manufacturing delay

Sagent Pharmaceuticals (Revised 01/13/2017)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25mg 30mL vial, (NDC 25021-164-30) Product is backordered. Estimated availability: January 2017. Demand increase for the drug
3.375g 30mL vial, (NDC 25021-165-30) Product is backordered. Estimated availability: January 2017. Demand increase for the drug
4.5g 48mL vial, (NDC 25021-166-48) Product is backordered. Estimated availability: January 2017. Demand increase for the drug

Sandoz (Revised 03/16/2017)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25g (NDC 0781-3344-95) Product temporarily unavailable. Other
4.5g (NDC 00781-3114-95) Available Other
3.375g (NDC 00781-3113-95) Available Other
2.25g (NDC 00781-3110-95) Available Other
3.375g (NDC 00781-9350-95) Product temporarily unavailable. Other
3.375g (NDC 00781-3350-95) Product temporarily unavailable. Other
4.5g (NDC 00781-3367-95) Product temporarily unavailable. Other
4.5g (NDC 00781-9367-95) Product temporarily unavailable. Other
2.25g (NDC 00781-9344-95) Product temporarily unavailable. Other

SteriMax, Inc. (New 02/24/2017)

Company Contact Information:
800-881-3550

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
3.375 gm/vial (NDCs 39822-9993-3 and 39822-9993-4) Available In conjunction with the FDA, SteriMax, Inc. has initiated temporary importation of Piperacillin and Tazobactam for Injection into the U.S. market, and X-Gen Pharmaceuticals will distribute this product to address the critical shortage. Please see the Dear Healthcare Professional Letter for additional product and supply information.

Dear Healthcare Professional Letter

Other
4.5 gm/vial (NDCs 39822-9994-5 and 39822-9994-6) Available In conjunction with the FDA, SteriMax, Inc. has initiated temporary importation of Piperacillin and Tazobactam for Injection into the U.S. market, and X-Gen Pharmaceuticals will distribute this product to address the critical shortage. Please see the Dear Healthcare Professional Letter for additional product and supply information.

Dear Healthcare Professional Letter

Other
40.5 gm/vial (NDC 39822-9995-7) Available In conjunction with the FDA, SteriMax, Inc. has initiated temporary importation of Piperacillin and Tazobactam for Injection into the U.S. market, and X-Gen Pharmaceuticals will distribute this product to address the critical shortage. Please see the Dear Healthcare Professional Letter for additional product and supply information.

Dear Healthcare Professional Letter

Other

WG Critical Care (Reverified 04/18/2016)

Company Contact Information:
888-493-0861

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25g (NDC 44567-0801-10) Product on backorder Product continues to be manufactured, please check wholesalers for inventory. Increased demand for the product.
3.375g (NDC 44567-0802-10) Product on backorder Product continues to be manufactured, please check wholesalers for inventory. Increased demand for the product.
4.5g (NDC 44567-0803-10) Product on backorder Product continues to be manufactured, please check wholesalers for inventory. Increased demand for the product.
40.5g (NDC 44567-0804-01) Product on backorder Product continues to be manufactured, please check wholesalers for inventory. Increased demand for the product.

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