US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 29, 2015 (11 years ago)

Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
PD-Rx Pharmaceuticals, Inc.
Origin
OK, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0561-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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