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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 61725
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 2012-04-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 Lot number 6A007046V, exp 07/12 Class III Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life 13,232 bottles D-128-2013