Drug recall D-1609-2014

Class III Terminated reported Oct 1, 2014

Product

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

Reason for recall

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

Lots and codes

Lot # KM4951; Exp. 04/15

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
5,397 bottles
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
April 18, 2014
Terminated
April 7, 2017

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