Enforcement Report - Week of January 23, 2013
-
Back to Previous Page
Product Detail
| Product Description | 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 |
| Classification | Class III |
| Code Info | Lot #160017A, Exp 04/2013. |
| Product Distributed Qty | 3,553 bottles |
| Reason For Recall | Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite. |
Event Detail
| Event Id | 63952 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Boehringer Ingelheim Roxane Inc |
| City | Columbus |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
-
