Sodium bicarbonate injection vials recalled for lack of assurance of sterility
Hospira 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL, lot LH2671, is recalled nationwide for lack of assurance of sterility. 15,750 vials are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an injectable medicine is a potential harm and no injuries are reported.
Plain-English summary
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), from Hospira, Inc. of Lake Forest, Illinois, NDC 0409-6637-24 with case NDC 00409-6637-14, is being recalled. The prescription-only product is affected in lot LH2671 with an expiry of 11/30/2026. The recall covers 15,750 vials distributed nationwide.
The recall was issued for lack of assurance of sterility. The FDA classified the action as Class II.
Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow Hospira's instructions for return or replacement.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- PFIZER INC
- Category
- Drug — Injectable
- Affected units
- 15,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: LH2671
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by PFIZER INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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