Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
Recall Number: D-1607-2014
Firm: Alvogen, Inc
Classification: Class II
Status: Terminated
Report Date: 20141001
Initiation Date: 20140828
Termination Date: 20150430
Reason for Recall
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Product Description
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.