Recalls / Class II
Class IID-0561-2016
Product
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.
- Affected lot / code info
- Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.
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.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 17,533 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-29
- FDA classified
- 2016-01-05
- Posted by FDA
- 2016-01-13
- Terminated
- 2016-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0561-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.