FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Sodium Bicarbonate Injection, USP
Status: Currently in Shortage
»Date first posted: 03/01/2017
»Therapeutic Categories: Endocrinology/Metabolism; Gastroenterology; Pediatric

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Amphastar Pharmaceuticals, Inc./IMS (Reverified 08/20/2018)

Company Contact Information:
800-423-4136

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sodium Bicarbonate Inj. USP, 8.4%, 50mL Luer-Jet Prefilled Syringe, (NDC 0548-3352-00), (new NDC 76329-3352-1) Available Please check with your wholesaler for available inventory. Demand increase for the drug

Athenex Pharmaceutical Division, LLC (Athenex) (Reverified 10/22/2018)

Company Contact Information:
855-273-0154

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sodium Bicarbonate Injection, 8.4% (1mEq/mL), 10mL per vial, 10 vials per carton (NDC 71456-001-01) Available Due to the current critical shortage of Sodium Bicarbonate Injection, USP in the United States (US) market, Athenex Pharmaceutical Division, LLC (Athenex) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Sodium Bicarbonate Injection. Athenex has initiated temporary importation of another manufacturer’s 8.4% Sodium Bicarbonate Injection (1 mEq/mL) 10 mL into the U.S. market. This product is manufactured and marketed in Australia by Phebra Pty Ltd (Phebra).

Dear Healthcare Professional Letter

Available

Fresenius Kabi USA, LLC (Revised 11/08/2018)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4.2% Single dose vial, 2.5 mEq per 5 mL (0.5 mEq per mL) (42 mg per mL)(NDC 63323-083-05) Available Check wholesalers for inventory Demand increase for the drug
8.4% Single dose vial, 50 mEq per 50 mL (1 mEq per mL) (84 mg per mL)(NDC 63323-089-50) Backordered. Next release November 2018. Check wholesalers for inventory Demand increase for the drug

Hospira, Inc. (Revised 11/08/2018)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Neut (Sodium Bicarbonate Additive Solution); 200 mg/5 mL (4%); Single Dose Glass Fliptop Vial (NDC 00409-6609-02) Next Delivery and Estimated Recovery: January 2019 Shortage per Manufacturer: Manufacturing Delay Other
Infant; 5 mEq/10 mL (4.2%; 0.5 mEq/mL); LifeShield Abboject Glass Syringe (NDC 00409-5534-34) Limited Supply Available. Next Delivery: January 2019; Estimated Recovery: June 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other
44.6 mEq/50 mL (7.5%; 0.9 mEq/mL); LifeShield Abboject Glass Syringe (NDC 00409-4916-34) Limited Supply Available. Next Delivery and Estimated Recovery: June 2019 Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter

Other
50 mEq/50 mL (8.4%; 1 mEq/mL); Single Dose Glass Fliptop Vial (NDC 00409-6625-02) Limited Supply Available. Next Delivery: November 2018; Estimated Recovery: March 2019 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages


Dear Customer Letter
Other
50 mEq/50 mL (8.4%; 1 mEq/mL); LifeShield Abboject Glass Syringe (NDC 00409-6637-34) Limited Supply Available. Next Delivery: June 2019; Estimated Recovery: September 2019 Shortage per Manufacturer: Manufacturing Delay

Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages


Dear Customer Letter
Other
Pediatric; 10 mEq/10 mL (8.4%; 1 mEq/mL); LifeShield Abboject Glass Syringe (NDC 00409-4900-34) Next Delivery: November 2018; Estimated Recovery: December 2018 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay Other

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