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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64680
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01 NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015. Class III CGMP Deviation; cotton coil is missing in some packaged bottles 68,322 bottles D-578-2013