Status
Terminated
Drug Enforcement D-343-2014
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Classification
Class III
Report Date
December 18, 2013
Termination Date
February 12, 2014
Product Information
- Product description
- Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
- Product quantity
- 8,550 cartons and bottles
- Reason for recall
- SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Address
-
1809 Wilson Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-343-2014
- Event ID
- 66288
- Recall initiation date
- March 18, 2013
- Center classification date
- December 11, 2013
- Code info
- Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
- More code info
- —