Home / Recalls / Apotex Scientific, Inc / D-1436-2016

D-1436-2016 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: 605,989 (30 ct) bottles

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;

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 #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016; Lot #: KY9961, Exp 04/30/2016; Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.