Recalls / Class II
Class IID-0591-2025
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.
- Brand name
- Sodium Bicarbonate
- Generic name
- Sodium Bicarbonate
- Active ingredient
- Sodium Bicarbonate
- Route
- Intravenous
- NDCs
- 0409-6637, 0409-4916
- FDA application
- ANDA202494
- Affected lot / code info
- Lot #: LH2671, Exp. 11/30/2026
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- PFIZER INC
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 68 Hudson Blvd E, N/A, New York, New York 10001-2188
Distribution
- Quantity
- 15,750 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-08-04
- FDA classified
- 2025-08-18
- Posted by FDA
- 2025-08-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0591-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.