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

FDA recall notice · announced January 22, 2014 · Pfizer

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

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

Notes

Distribution: Nationwide and Puerto Rico
Lot/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
Quantity: 101,681 Vials
Status: Terminated
Products in this recall event:
- 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 10 (D-745-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.