US Drug Recall Register
Class III · Low risk Terminated Initiated Dec 12, 2012 (14 years ago)

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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

Recalling firm
Boehringer Ingelheim Roxane Inc
NDC code
0054-0112-25
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-126-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.