FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Cefepime Injection
Status: Currently in Shortage
»Date first posted: 07/22/2015
»Therapeutic Categories: Anti-Infective; Pediatric

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Apotex Corp. (Revised 06/15/2016)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Cefepime for Injection, USP 1 gm (10 Vials) (NDC 60505-6030-4) Backorder expected to resolve by July 2016 We are on backorder due to increase in demand from customers that have been exceeding forecasts. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for Injection, USP 2 gm (10 Vials)(NDC 60505-6031-4) Backorder expected to resolve by July 2016 We are on backorder due to increase in demand from customers that have been exceeding forecasts. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (10 Vials) (NDC 60605-0834-04) On backorder. Backorder expected to resolve by July 2016. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-4) On backorder. Backorder expected to resolve by July 2016. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (1 Vial) (NDC 60505-0834-00) On backorder. Backorder expected to resolve by July 2016. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-0) On backorder. Backorder expected to resolve by July 2016. Requirements relating to complying with current good manufacturing practices (cGMP).

B. Braun Medical Inc. (New 07/22/2015)

Company Contact Information:
800-227-2862

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Cefepime 1 g (NDC 0264-3193-11) On allocation to contract customers only due to increase in product demand. No interruption in supply. Demand increase for the drug
Cefepime 2 g (NDC 0264-3195-11) Available. No interruption in supply. Demand increase for the drug

Baxter Healthcare (Reverified 05/25/2016)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Cefepime Injection, 1 gram/50mL, GALAXY Container (NDC 0338-1301-41) Available for existing customers. Demand increase for the drug
Cefepime Injection, 2 gram/100mL, GALAXY Container (NDC 0338-1301-48) Available for existing customers. Demand increase for the drug

Fresenius Kabi USA, LLC (Revised 06/15/2016)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 g single dose vial, sterile powder (NDC 63323-326-20) Backordered. Next release anticipated Q3 - 2016 Check wholesalers for inventory. Demand increase for the drug
2 g single dose vial, sterile powder (NDC 63323-340-20) Backordered. Next release anticipated Q2 - 2016 Demand increase for the drug

Hospira, Inc. (Reverified 06/14/2016)

Company Contact Information:
877-946-7747

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2g Single Dose ADD-Vantageā„¢ Glass Vial (NDC 0409-0218-01) Next delivery: July 2016; Estimated recovery: 4Q 2016. Shortage per Manufacturer: Manufacturing delay Other
1g Single Dose ADD-Vantageā„¢ Glass Vial (NDC 0409-0217-01) Available Shortage per Manufacturer: Available Other
1g Single Dose Glass Fliptop Vial (NDC 0409-0219-01) Available, Releasing product consistently Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available Demand increase for the drug
2g Single Dose Glass Fliptop Vial (NDC 0409-0220-01) Available, releasing product consistently Please check with your wholesaler for available inventory. Shortage per Manufacturer: Available Demand increase for the drug

Sagent Pharmaceuticals (Reverified 05/16/2016)

Company Contact Information:
866-625-1618

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 g vial (NDC 25021-121-20) Available Demand increase for the drug
2 g vial (NDC 25021-122-50) Product is on allocation Demand increase for the drug

WG Critical Care (Revised 06/08/2016)

Company Contact Information:
888-493-0861

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
1 g vial (NDC 44567-0240-10) Backordered Please check wholesalers and distributors for inventory. Demand increase for the drug
2 g vial (NDC 44567-0241-10) Backordered Please check wholesalers and distributors for inventory. Demand increase for the drug

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