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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65780
Product Type Drugs
Status Ongoing
Recalling Firm Torrent Pharma Inc
City Kalamazoo
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30 Lot #: BS392004A, Exp: 09/2014 Class II Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application. 18,721 bottles D-830-2013
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