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U.S. Department of Health and Human Services

Enforcement Report - Week of May 20, 2015

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Product Detail

Product Description Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Recall Number D-1079-2015
Classification Class III
Code Info Lot #: a) KL0655, Exp 04/15; KY2374, Exp 05/16; b) KL0656, Exp 04/15; KY2371, Exp 05/16
Product Distributed Qty 23,274 bottles/ blister cartons
Reason For Recall Subpotent drug

Event Detail

Event Id 71046
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Inc.
City Toronto
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-04-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide