PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: January 22, 2014 Initiated: January 2, 2014 #D-745-2014

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

Reason for Recall

Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.

Details

Recalling Firm
Pfizer Inc.
Units Affected
101,681 Vials
Distribution
Nationwide and Puerto Rico
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 101,681 Vials.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Low. Recall number: D-745-2014.