Recalls / Class III
Class IIID-343-2014
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
- Affected lot / code info
- Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014
Why it was recalled
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 8,550 cartons and bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-03-18
- FDA classified
- 2013-12-11
- Posted by FDA
- 2013-12-18
- Terminated
- 2014-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-343-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.