Drug 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.
D-0591-2025
Product summary
- Firm
- PFIZER INC
- Event
- Event 97364
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,750 vials
- Official record key
drug-enforcement:D-0591-2025
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: LH2671, Exp. 11/30/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility