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

Hospira a Pfizer Company
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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