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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide