Home / Recalls / Boehringer Ingelheim Roxane Inc / D-126-2013

D-126-2013 Class III Terminated

Recalled by Boehringer Ingelheim Roxane Inc — Columbus, OH

Recall Details

Product Type: Drugs
Report Date: January 23, 2013
Initiation Date: December 12, 2012
Termination Date: June 16, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,553 bottles

Product Description

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.

Reason for Recall

Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.

Distribution Pattern

Nationwide

Code Information

Lot #160017A, Exp 04/2013.

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