FDA Recall D-0591-2025
PFIZER INC · New York, NY
Class II Ongoing 283 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Lack of Assurance of Sterility.
Recall record
- Recall number
D-0591-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-08-04
- Classified by FDA Center
- 2025-08-18
- FDA published
- 2025-08-27
- Recalling firm
- PFIZER INC
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- SODIUM BICARBONATE
- Generic name(s)
- SODIUM BICARBONATE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-6637, 0409-4916- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.