Zithromax — Class III drug recall D-745-2014
Terminated recall by Pfizer Inc., reported 2014-01-22, distributed nationwide. Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification res
| Recall number | D-745-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2014-01-02 |
| Classified | 2014-01-16 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2016-03-14 |
| Distributed | Nationwide (US) |
| Quantity | 101,681 vials |
| Reason classes | specification failure |
| NDC | 00069-3150, 00069-3150-83, 00069-3150-84 |
| Lot numbers | 0B0CJ, G44710, G65241, G80003, G81845, G82722, G93028, G95309, G97641 |
| Expiration dates | 2014-10-03, 2015-02-06, 2015-07-10, 2015-07-11, 2015-10-17, 2015-11-27, 2016-01-23, 2016-01-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-745-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.