FDA-Drug2017-08-09Class II

8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

Hazard

Lack of Sterility Assurance

Sold states
U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Affected count
91,483,150 50 mL single dose vials
Manufactured in
4285 N Wesleyan Blvd, N/A, Rocky Mount, NC, United States
Products
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1047-2017

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