August 2017 FDA Recall Vancomycin Hydrochloride by Pfizer Inc.
D-0123-2018 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Pfizer Inc. on August 30, 2017 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-0123-2018
Presence of Particulate Matter: glass particulate found in vial
08-30-2017
12-27-2017
102,500 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.
Nationwide USA and Puerto Rico
11-08-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Batch or Lot Expiration Information
Lot# Lot: 632153A; Exp. 03/18
