FDA-Drug2025-08-27Class II

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

PFIZER INC
Hazard

Lack of Assurance of Sterility.

Sold states
U.S. Nationwide
Affected count
15,750 vials
Manufactured in
68 Hudson Blvd E, N/A, New York, NY, United States
Products
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0591-2025

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