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

Firm: Boehringer Ingelheim Roxane Inc

Classification: Class III

Status: Terminated

Report Date: 20130123

Initiation Date: 20121212

Termination Date: 20140616

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

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