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Recall Observatory FDA recall evidence

Drug 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

D-745-2014

January 02, 2014

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 67137
Status
Terminated
Classification
Class III
Quantity
101,681 Vials
Official record key
drug-enforcement:D-745-2014

Official wording

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

Code information: 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

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification

Field note

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