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. (Revised 08/27/2019)

Company Contact Information:
800-881-3550

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
3.375 g, single dose vial, box of 10 (NDC 39822-0125-4) Available - Less than one year dating Marketed by X-GEN Pharmaceuticals, Inc. To order, contact X-GEN at 1-866-390-4411.
2.25 g, single dose vial, box of 10 (NDC 39822-0123-2) Available Marketed by X-GEN Pharmaceuticals, Inc. To order, contact X-GEN at 1-866-390-4411
4.5 g, single dose vial, box of 10 (NDC 39822-0127-6) Discontinued
40.5 g, pharmacy bulk vial (NDC 39822-0139-7) Available - Less than one year dating Marketed by X-GEN Pharmaceuticals, Inc. To order, contact X-GEN at 1-866-390-4411
3.375 g, single dose vial, box of 10 (NDC 61990-0120-2) Available Marketed by Apollo Pharmaceuticals Inc. Check wholesalers for inventory.
13.5 g, pharmacy bulk vial (NDC 61990-0140-2) Available Marketed by Apollo Pharmaceuticals Inc. Check wholesalers for inventory.
40.5 g, pharmacy bulk vial (NDC 61990-0150-2) Available Marketed by Apollo Pharmaceuticals Inc. Check wholesalers for inventory.
2.25 g, single dose vial, box of 10 (NDC 61990-0110-2) Available Marketed by Apollo Pharmaceuticals Inc. Check wholesalers for inventory.
4.5 g, single dose vial, box of 10 (NDC 61990-0130-2) Available Marketed by Apollo Pharmaceuticals Inc. Check wholesalers for inventory.

Aurobindo Pharma (Revised 08/22/2019)

Company Contact Information:
888-238-7880

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g, single dose vial, box of 10 (NDC 55150-119-30) Available Marketed by AuroMedics Pharma LLC. Check wholesalers for inventory.
3.375 g, single dose vial, box of 10 (NDC 55150-120-30) Available Marketed by AuroMedics Pharma LLC. Check wholesalers for inventory.
4.5 g, single dose vial, box of 10 (NDC 55150-121-50) Available Marketed by AuroMedics Pharma LLC. Check wholesalers for inventory.
2.25 g, single dose vial, box of 10 (NDC 25021-164-30) Available Marketed by Sagent Pharmaceuticals. To order, contact Sagent at 1-866-625-1618.
3.375 g, single dose vial, box of 10 (NDC 25021-165-30) Available Marketed by Sagent Pharmaceuticals. To order, contact Sagent at 1-866-625-1618.
4.5 g, single dose vial, box of 10 (NDC 25021-166-48) Backordered. Estimated availability August 2019 Marketed by Sagent Pharmaceuticals. To order, contact Sagent at 1-866-625-1618. Demand increase for the drug

Fresenius Kabi USA, LLC (Reverified 10/18/2019)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
3.375 g, single dose vial, box of 10 (NDC 63323-983-21) Available Check wholesalers for inventory. Demand increase for the drug
4.5 g, single dose vial, box of 10 (NDC 63323-0982-52) Available Check wholesalers for inventory. Demand increase for the drug
3.375 g, single-dose vial (63323-983-21) Available Check wholesalers for inventory. Demand increase for the drug
4.5 g, single-dose vial (63323-0982-52) Available Check wholesalers for inventory. Demand increase for the drug
2.25 g, single-dose vial (NDC 63323-981-21) Available Check wholesalers for inventory. Demand increase for the drug

Istituto Biochimico Italiano SpA (Revised 08/27/2019)

Company Contact Information:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g, single dose vial, box of 10 (NDC 70860-120-20) Available Marketed by Athenex Pharmaceutical Division, LLC
3.375 g, single dose vial, box of 10 (NDC 70860-121-30) Available Marketed by Athenex Pharmaceutical Division, LLC
4.5 g, single dose vial, box of 10 (NDC 70860-122-50) Available Marketed by Athenex Pharmaceutical Division, LLC
40.5 g, pharmacy bulk bottle (NDC 70860-123-99) Available Marketed by Athenex Pharmaceutical Division, LLC
40.5 g, pharmacy bulk bottle (NDC 63323-304-74) Available Marketed by Fresenius Kabi USA, LLC. Check wholesalers for inventory.
2.25 g, single dose vial, box of 10 (NDC 63323-309-20) Available Marketed by Fresenius Kabi USA, LLC. Check wholesalers for inventory.
2.25 g, single dose vial, box of 10 (NDC 44567-801-10) Available Marketed by WG Critical Care. Product continues to be manufactured, please check wholesalers for inventory.
3.375 g, single dose vial, box of 10 (NDC 44567-802-10) Available Marketed by WG Critical Care. Product continues to be manufactured, please check wholesalers for inventory.
4.5 g, single dose vial, box of 10 (NDC 44567-803-10) Available Marketed by WG Critical Care. Product continues to be manufactured, please check wholesalers for inventory.
40.5 g, pharmacy bulk bottle (NDC 44567-804-01) Available Marketed by WG Critical Care. Product continues to be manufactured, please check wholesalers for inventory.
3.375 g, single dose vial, box of 10 (NDC 0781-9350-95) Novaplus Permanently discontinued Marketed by Sandoz, Inc.
2.25 g, single dose vial, box of 10 (NDC 0781-3344-95) Permanently discontinued Marketed by Sandoz, Inc.
3.375 g, single dose vial, box of 10 (NDC 0781-3350-95) Permanently discontinued Marketed by Sandoz, Inc.
4.5 g, single dose vial, box of 10 (NDC 0781-3367-95) Permanently discontinued Marketed by Sandoz, Inc.
4.5 g, single dose vial, box of 10 (NDC 0781-9367-95) Novaplus Permanently discontinued Marketed by Sandoz, Inc.
2.25 g, single dose vial, box of 10 (NDC 0781-9344-95) Novaplus Permanently discontinued Marketed by Sandoz, Inc.

Mylan Institutional (Reverified 10/18/2019)

Company Contact Information:
800-RXMYLAN (1-800-796- 9526)

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

Pfizer Pharmaceuticals (Reverified 10/07/2019)

Company Contact Information:
800-533-4535

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Zosyn; 2.25 g/50 mL, frozen IV bag (NDC 0206-8860-02) Available
Zosyn; 3.375 g/50 mL, frozen IV bag (NDC 0206-8861-02) Available
Zosyn; 4.5 g/100 mL, frozen IV bag (NDC 0206-8862-02) Available
Zosyn 2.25 g, single dose vial, box of 10 (NDC 0206-8852-16) Next Delivery and Estimated Recovery: March 2020 Shortage per manufacturer: Manufacturing Delay Other
Zosyn; 3.375 g, single dose vial, box of 10 (NDC 0206-8854-16) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay Other
Zosyn; 4.5 g, single dose vial, box of 10 (NDC 0206-8855-16) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay Other
Zosyn; 40.5 g, pharmacy bulk vial (NDC 0206-8859-10) Next Delivery and Estimated Recovery: March 2020 Shortage per Manufacturer: Manufacturing Delay Other

Qilu Tianhe Pharmaceutical Co., Ltd. (Reverified 09/18/2019)

Company Contact Information:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g, single dose vial, box of 10 (NDC 60505-6156-4) Available Marketed by Apotex Corp. To order, contact Apotex at 800-706-5575.
3.375 g, single dose vial, box of 10 (NDC 60505-6157-4) Available Marketed by Apotex Corp. To order, contact Apotex at 800-706-5575.
4.5 g, single dose vial, box of 10 (NDC 60505-6159-4) Available Marketed by Apotex Corp. To order, contact Apotex at 800-706-5575.

Sandoz (Reverified 10/17/2019)

Company Contact Information:
800-525-8747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.25 g, single dose vial, box of 10 (NDC 0781-9210-95) Novaplus Available
4.5 g, single dose vial, box of 10 (NDC 0781-9214-95) Novaplus Available
3.375 g, single dose vial, box of 10 (NDC 0781-9213-95) Novaplus Available
3.375 g, single dose vial, box of 10 (NDC 0409-3378-13) ADD-Vantage Available Marketed by Hospira.
4.5 g, single dose vial, box of 10 (NDC 0409-3379-04) ADD-Vantage Available Marketed by Hospira.
2.25 g, single dose vial, box of 10 (NDC 0409-3383-02) Available Marketed by Hospira.
3.375 g, single dose vial, box of 10 (NDC 0409-3385-13) Available Marketed by Hospira.
4.5 g, single dose vial, box of 10 (NDC 0409-3390-04) Available Marketed by Hospira.
13.5 g, pharmacy bulk bottle (NDC 0409-2999-14) Available Marketed by Hospira.
4.5 g, single dose vial, box of 10 (NDC 0781-3114-95) Available
3.375 g, single dose vial, box of 10 (NDC 0781-3113-95) Available
2.25 g, single dose vial, box of 10 (NDC 0781-3110-95) Available
2.25 g, single dose vial, box of 10 (NDC 0409-3374-02) ADD-Vantage Next Delivery: September 2019; Estimated Recovery: October 2019 Marketed by Hospira. Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other

Wockhardt (Revised 10/09/2019)

Company Contact Information:
800-346-6854

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4g/0.5g (4.5 g) per SDV; 10 SDVs/carton (NDC 64679-0012-01) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
4g/0.5g (4.5 g) per SDV; 1 SDV/carton (NDC 64679-0012-02) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
2g/0.25g (2.25 g) per SDV; 10 SDVs/carton (NDC 64679-0034-01) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
2g/0.25g (2.25 g) per SDV; 1 SDV/carton (NDC 64679-0034-02) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
3g/0.375g (3.375 g) per SDV; 10 SDVs/carton (NDC 64679-0056-01) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
3g/0.375g (3.375 g) per SDV; 1 SDV/carton (NDC 64679-0056-02) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
36g/4.5g (40.5 g) per vial (Pharmacy Bulk Pack); one vial/carton (NDC 64679-0679-01) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019
36g/4.5g (40.5 g) per vial (Pharmacy Bulk Pack); 10 vials/carton (NDC 64679-0679-02) Backordered material arrived in end of September; stock sold out and new batches on backorder until week of 10/14/2019

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