Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Recall Number: D-1609-2014

Firm: Apotex Corp.

Classification: Class III

Status: Terminated

Report Date: 20141001

Initiation Date: 20140418

Termination Date: 20170407

Reason for Recall

Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Product Description

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03