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.
Reported: January 13, 2016 Initiated: April 29, 2015 #D-0560-2016
Product Description
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.
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
- 45,022 bottles
- Distribution
- Nationwide
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product 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.. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 45,022 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-0560-2016.
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