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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description 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
Recall Number D-830-2013
Classification Class II
Code Info Lot #: BS392004A, Exp: 09/2014
Product Distributed Qty 18,721 bottles
Reason For Recall 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.

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
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