# FDA recall D-745-2014

> **Pfizer Inc.** · Class III · drug recall initiated 2014-01-02.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-745-2014
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-02
- **Report date:** 2014-01-22
- **Termination date:** 2016-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-745-2014

## Citation

> AI Analytics. FDA recall D-745-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-745-2014. Source: US FDA. Licensed CC0.

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