FDA recall D-0184-2023

Product

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.

Distribution

USA nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2022-12-22

Report date

2023-02-01

Termination date

2024-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0184-2023