Drug Enforcement D-0234-2024

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
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).
Product quantity
21200 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-0234-2024
Event ID
93681
Recall initiation date
December 21, 2023
Center classification date
January 17, 2024
Code info
Lot HA7295, EXP 03/01/2025
More code info
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