← FDA ENFORCEMENT
D-0233-2024Class 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
34000 Cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter; identified as glass

Product description

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).

Code / lot info

Lot GX1542, Exp. 01/01/2025

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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.