FDA-Drug2016-01-13Class II

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.

PD-Rx Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide
Affected count
45,022 bottles
Manufactured in
727 N Ann Arbor Ave, N/A, Oklahoma City, OK, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0560-2016

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