Class III
Terminated
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
This recall has been terminated (originally issued December 18, 2013).
- Company
- Boehringer Ingelheim Roxane Inc
- Recall Initiated
- March 18, 2013
- Posted
- December 18, 2013
- Recall Number
- D-343-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,550 cartons and bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
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