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