Recall: D-0591-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-04Initiated

OngoingStatus

PFIZER INCFirm

Product

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.

Reason

Lack of Assurance of Sterility.

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.