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

FDA recall notice · announced February 1, 2023 · Pfizer

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: USA nationwide and Puerto Rico
Lot/code information: Lot: 33045BA, EXP 1SEP2023
Quantity: 89,700 vials
Status: Terminated
Products in this recall event:
- 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 0409-351 (D-0184-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.