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.
Reported: August 27, 2025 Initiated: August 4, 2025 #D-0591-2025
Product Description
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 for Recall
Lack of Assurance of Sterility.
Details
- Recalling Firm
- PFIZER INC
- Units Affected
- 15,750 vials
- Distribution
- U.S. Nationwide
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by PFIZER INC. Units affected: 15,750 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2025. Severity: Moderate. Recall number: D-0591-2025.
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