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

FDA recall notice · announced January 23, 2013 · Boehringer Ingelheim Roxane

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #160017A, Exp 04/2013.
Quantity: 3,553 bottles
Status: Terminated
Products in this recall event:
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. (D-126-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.