PlainRecalls
FDA Drug Critical Class I Terminated

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

Reported: February 1, 2023 Initiated: December 22, 2022 #D-0184-2023

Product Description

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

Reason for Recall

Presence of Particulate Matter: Glass particulate matter detected in injectable.

Details

Recalling Firm
Pfizer Inc.
Units Affected
89,700 vials
Distribution
USA nationwide and Puerto Rico
Location
New York, NY

Frequently Asked Questions

What product was recalled?
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01. Recalled by Pfizer Inc.. Units affected: 89,700 vials.
Why was this product recalled?
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2023. Severity: Critical. Recall number: D-0184-2023.