Home / Recalls / Apotex Scientific, Inc / D-1437-2016

D-1437-2016 Class III Terminated

Recalled by Apotex Scientific, Inc — Arlington, TX

Recall Details

Product Type: Drugs
Report Date: July 20, 2016
Initiation Date: January 26, 2016
Termination Date: June 15, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 750,273 (30 ct) bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide, Alaska, Hawaii, and Puerto Rico.

Code Information

Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016.