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.
Reported: January 13, 2016 Initiated: April 29, 2015 #D-0561-2016
Product Description
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.
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.
Details
- Recalling Firm
- PD-Rx Pharmaceuticals, Inc.
- Units Affected
- 17,533 bottles
- Distribution
- Nationwide
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product 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.. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 17,533 bottles.
Why was this product recalled? ▼
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 13, 2016. Severity: Moderate. Recall number: D-0561-2016.
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