Status
Terminated
Drug Enforcement D-126-2013
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Classification
Class III
Report Date
January 23, 2013
Termination Date
June 16, 2014
Product Information
- Product description
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
- Product quantity
- 3,553 bottles
- Reason for recall
- Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Address
-
1809 Wilson Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-126-2013
- Event ID
- 63952
- Recall initiation date
- December 12, 2012
- Center classification date
- January 16, 2013
- Code info
- Lot #160017A, Exp 04/2013.
- More code info
- —