January 2014 FDA Recall Zithromax by Pfizer Inc.
D-745-2014 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Pfizer Inc. on January 2, 2014 for the product Zithromax. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-745-2014

Reason for Recall
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Initiated
01-02-2014
Reported
01-22-2014
Quantity
101,681 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67137
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2016
Product Description About Product Description
Full technical description of the product.
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84

Batch or Lot Expiration Information

Lot# Lot Number/Expiration Date G81845, Exp 10/03/14 0B0CJ, Exp 02/06/15 G44710, Exp 07/10/15 G65241, Exp 07/11/15 G80003, Exp 10/17/15 G82722, Exp 11/27/15 G93028, G95309, Exp: 01/23/16 G97641, Exp 01/30/16

Affected Packages Involved in this Recall

0069-3150-84 Zithromax
0069-3150-83 Zithromax