Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
Recall Number: D-1436-2016
Firm: Apotex Scientific, Inc
Classification: Class III
Status: Terminated
Report Date: 20160720
Initiation Date: 20160126
Termination Date: 20220615
Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;