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 07/12/2017)

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

Fresenius Kabi USA, LLC (Revised 11/17/2017)

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 Please 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) Available Please check wholesalers for inventory. Demand increase for the drug

Hospira, Inc. (Revised 12/01/2017)

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: January 2018; Estimated recovery: March 2018 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: Early December 2017; Estimated recovery: March 2018 Limited supply available. 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: Mid February 2018; Estimated recovery: March 2018 Limited supply available. 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: Early December; Estimated recovery: December 2017 Limited supply available. Shortage per manufacturer: Manufacturing delay

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

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 December 2017; Estimated recovery: March 2018 Limited supply available. Shortage per manufacturer: Manufacturing delay

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

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: Mid February 2017; Estimated recovery: March 2018 Shortage per manufacturer: Manufacturing delay Other

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