Drug product
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
Product summary
- Event
- Event 63952
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,553 bottles
- Official record key
drug-enforcement:D-126-2013
Official wording
Reason: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Code information: Lot #160017A, Exp 04/2013.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification