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

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 Letter
Distribution Pattern Nationwide