PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: November 15, 2023 Initiated: October 2, 2023 #D-0100-2024

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.

Details

Recalling Firm
Pfizer Inc.
Units Affected
24,900 vials
Distribution
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 24,900 vials.
Why was this product recalled?
Presence of Particulate Matter: identified as glass.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 15, 2023. Severity: Critical. Recall number: D-0100-2024.