Azithromycin 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 Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceu…
- Recall number
- D-0560-2016
- 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 Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
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