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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 63952
Product Type Drugs
Status Ongoing
Recalling Firm Boehringer Ingelheim Roxane Inc
City Columbus
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. Lot #160017A, Exp 04/2013. Class III Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. 3,553 bottles D-126-2013