Zithromax Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0069-3150
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zithromax (NDC 0069-3150). A significant event, classified as Class III, was initiated on Jan 02, 2014 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2014 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Jan 02, 2014
Jan 22, 2014
101,681 Vials
Recall Profile & Regulatory Data
Event ID
67137
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 14, 2016
Product Description
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
0069-3150-84Product
0069-3150-83Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
