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 (New 03/01/2017)

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) (New 05/31/2017)

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) See Related Information 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

Other

Hospira, Inc. (Revised 06/16/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
[Neut™ (Sodium Bicarbonate Additive Solution)] 4% (200mg/5mL) Single Dose Glass Fliptop Vial (NDC 0409-6609-02) Next delivery: Early July 2017; Estimated recovery: 4Q 2017 Shortage per manufacturer: Manufacturing delay Other
(Infant) 4.2% (0.5 mEq/mL); 5 mEq/10 mL LifeShield™ Abboject™ Glass Syringe with Male Luer Lock Adapter and 20-Gauge protected needle (NDC 0409-5534-34) Next delivery: Late June 2017; Estimated recovery: 1Q 2018 Shortage per manufacturer: Manufacturing delay Other
7.5% (0.9 mEq/mL); 44.6 mEq/50 mL LifeShield™ Abboject™ Glass Syringe with Male Luer Lock Adapter and 18-Gauge protected needle (NDC 0409-4916-34) Next delivery: October 2017; Estimated recovery: 1Q 2018 Shortage per manufacturer: Manufacturing delay Other
8.4% (1 mEq/mL); 50 mEq/50 mL Single Dose Glass Fliptop Vial (NDC 0409-6625-02) Next delivery and estimated recovery: TBD Shortage per manufacturer: Manufacturing delay Other
8.4% (1 mEq/mL); 50 mEq/50 mL LifeShield™ Abboject™ Glass Syringe (18 G x 1 1/2“)(NDC 0409-6637-34) Next delivery: Early June; Estimated recovery: 1Q 2018 Shortage per manufacturer: Manufacturing delay Other
(Pediatric) 8.4% (1 mEq/mL); 10 mEq/10 mL LifeShield™ Abboject™ Glass Syringe with Male Luer Lock Adapter and 20-Gauge protected needle (NDC 0409-4900-34) Next delivery: Early August; Estimated recovery: 1Q 2018 Shortage per manufacturer: Manufacturing delay Other

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