Drug Enforcement D-0233-2024

Presence of Particulate Matter; identified as glass

Status

Ongoing

Classification

Class I

Report Date

January 24, 2024

Termination Date

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Product Information

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).
Product quantity
34000 Cartons
Reason for recall
Presence of Particulate Matter; identified as glass
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico.

Location & Firm

Recalling firm
Pfizer Inc.
Address
235 East 42nd Street, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0233-2024
Event ID
93681
Recall initiation date
December 21, 2023
Center classification date
January 17, 2024
Code info
Lot GX1542, Exp. 01/01/2025
More code info
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