Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

Recall Number: D-1437-2016

Firm: Apotex Scientific, Inc

Classification: Class III

Status: Terminated

Report Date: 20160720

Initiation Date: 20160126

Termination Date: 20220615

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.