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. (Reverified 08/23/2016)

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) On backorder. Shortage duration is unknown. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for Injection, USP 2 gm (10 Vials)(NDC 60505-6031-4) On backorder. Shortage duration is unknown. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (10 Vials) (NDC 60605-0834-04) On backorder. Shortage duration is unknown. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-4) On backorder. Shortage duration is unknown. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (1 Vial) (NDC 60505-0834-00) On backorder. Shortage duration is unknown. Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-0) On backorder. Shortage duration is unknown. 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 08/09/2016)

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 (Reverified 08/15/2016)

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 Q4 - 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 Q4 - 2016 Demand increase for the drug

Hospira, Inc. (Reverified 08/12/2016)

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: Dec 2016; Estimated recovery: 4Q 2016 Shortage per Manufacturer: Manufacturing delay Other
1g Single Dose ADD-Vantageā„¢ Glass Vial (NDC 0409-0217-01) Next delivery: Dec 2016; Estimated recovery: 4Q 2016 Shortage per Manufacturer: Manufacturing delay Other
1g Single Dose Glass Fliptop Vial (NDC 0409-0219-01) Next delivery: August 2016; Estimated recovery: 4Q 2016 Shortage per Manufacturer: Manufacturing delay Other
2g Single Dose Glass Fliptop Vial (NDC 0409-0220-01) Next delivery: August 2016; Estimated recovery: 2017 Shortage per Manufacturer: Manufacturing delay Other

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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