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4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syring...

FDA Recall #D-0100-2024 — Class I — October 2, 2023

Recall #D-0100-2024 Date: October 2, 2023 Classification: Class I Status: Terminated

Product Description

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

Reason for Recall

Presence of Particulate Matter: identified as glass.

Recalling Firm

Pfizer Inc. — New York, NY

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

24,900 vials

Distribution

Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

Code Information

Lot#: GJ5007, Exp. 8/1/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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