Status
Ongoing
Drug Enforcement D-0591-2025
Lack of Assurance of Sterility.
Classification
Class II
Report Date
August 27, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 15,750 vials
- Reason for recall
- Lack of Assurance of Sterility.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
Location & Firm
- Recalling firm
- Pfizer Inc
- Address
-
68 Hudson Blvd E, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0591-2025
- Event ID
- 97364
- Recall initiation date
- August 4, 2025
- Center classification date
- August 18, 2025
- Code info
- Lot #: LH2671, Exp. 11/30/2026
- More code info
- —