← FDA ENFORCEMENT
D-0234-2024Class I

Pfizer Inc.

Recalling firm
Pfizer Inc.
Product type
Drug
Status
Ongoing
Report date
2024-01-24
Distribution
Nationwide in the USA and Puerto Rico.
Firm state
NY
Product quantity
21200 Cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter; identified as glass

Product description

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).

Code / lot info

Lot HA7295, EXP 03/01/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.