FDA recall D-126-2013

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-12

Report date

2013-01-23

Termination date

2014-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-126-2013