FDA Drug recall D-126-2013
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC…
- FDA Drug
- Class III
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class III recall of Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC… by Boehringer Ingelheim Roxane, citing impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-126-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-12 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Reason
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Identifiers
| code_info | Lot #160017A, Exp 04/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-126-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.