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 08/09/2017)

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) Available Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for Injection, USP 2 gm (10 Vials)(NDC 60505-6031-4) Available Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (10 Vials) (NDC 60605-0834-04) Available Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-4) Available Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 1 gm (1 Vial) (NDC 60505-0834-00) Available Requirements relating to complying with current good manufacturing practices (cGMP).
Cefepime for injection, USP 2 gm (10 Vials) (NDC 60505-0681-0) Available 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 09/12/2017)

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 Other
Cefepime Injection, 2 gram/100mL, GALAXY Container (NDC 0338-1301-48) Available Other

Fresenius Kabi USA, LLC (Reverified 09/11/2017)

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) Available Check wholesalers for inventory Demand increase for the drug
2 g single dose vial, sterile powder (NDC 63323-340-20) Available Check wholesalers for inventory Demand increase for the drug

Hospira, Inc. (Revised 09/21/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2g Single Dose ADD-Vantage™ Glass Vial (NDC 0409-0218-01) Next delivery: Late September 2017; Estimated recovery: December 2017 Shortage per Manufacturer: Manufacturing delay Other
1g Single Dose ADD-Vantage™ Glass Vial (NDC 0409-0217-01) Next delivery: Mid October 2017; Estimated recovery: November 2017 Shortage per Manufacturer: Manufacturing delay Other
1g Single Dose Glass Fliptop Vial (NDC 0409-0219-01) Available Available Other
2g Single Dose Glass Fliptop Vial (NDC 0409-0220-01) Available Available Other

Sagent Pharmaceuticals (Revised 03/20/2017)

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) On backorder. Estimated delivery: June 2017 Manufacturing delay
2 g vial (NDC 25021-122-50) On backorder. Estimated delivery: April 2017 Manufacturing delay

WG Critical Care (Reverified 08/10/2017)

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) Available Please check wholesalers and distributors for inventory. Demand increase for the drug
2 g vial (NDC 44567-0241-10) Available Please check wholesalers and distributors for inventory. Demand increase for the drug

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