Azithromycin 500 mg tablets recalled over manufacturing violations

Recall date

April 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

PD-Rx Pharmaceuticals, Inc. recalls Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged…

Recall number

D-0561-2016

FDA classification

Class II

Brand / firm

PD-Rx Pharmaceuticals, Inc.

Sold / distributed

Nationwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.