Drug product
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
D-343-2014
Product summary
- Event
- Event 66288
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,550 cartons and bottles
- Official record key
drug-enforcement:D-343-2014
Official wording
Reason: SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Code information: Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
SubPotent