Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane ...
FDA Recall #D-126-2013 — Class III — December 12, 2012
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.
Recalling Firm
Boehringer Ingelheim Roxane Inc — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3,553 bottles
Distribution
Nationwide
Code Information
Lot #160017A, Exp 04/2013.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated