# FDA recall D-0561-2016

> **PD-Rx Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-04-29.

## Product

Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.

## Reason for recall

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0561-2016
- **Recalling firm:** PD-Rx Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-29
- **Report date:** 2016-01-13
- **Termination date:** 2016-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2016

## Citation

> AI Analytics. FDA recall D-0561-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0561-2016. Source: US FDA. Licensed CC0.

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