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.

FDA recall notice · announced January 13, 2016 · Pd-rx Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.
Quantity: 45,022 bottles
Status: Terminated
Products in this recall event:
- 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., Mum (D-0561-2016)
- 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: (D-0560-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.