November 2014 FDA Recall Vancomycin Hydrochloride by Hospira Inc.
D-0254-2015 - Correct Labeled Product Mispack
This Class III drug recall was voluntarily initiated by Hospira Inc. on November 7, 2014 for the product Vancomycin Hydrochloride. The FDA reported the reason for recall as correct labeled product mispack. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0254-2015
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
11-07-2014
11-26-2014
316,640 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Hospira 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
03-22-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
Batch or Lot Expiration Information
Lot# 43-240-DD; Exp. 07/16
Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
