December 2022 FDA Recall Vancomycin Hydrochloride by Pfizer Inc.
D-0184-2023 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Pfizer Inc. on December 22, 2022 for the product Vancomycin Hydrochloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0184-2023
Presence of Particulate Matter: Glass particulate matter detected in injectable.
12-22-2022
02-01-2023
89,700 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide and Puerto Rico
08-07-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# Lot: 33045BA, EXP 1SEP2023
