D-343-2014 Class III Terminated
FDA drug recall D-343-2014 was initiated by Boehringer Ingelheim Roxane Inc on March 18, 2013 and is designated Class III. 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. The recall status is terminated (terminated February 12, 2014). Affected quantity: 8,550 cartons and bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2013
- Initiation Date
- March 18, 2013
- Termination Date
- February 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,550 cartons and bottles
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
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #: a) 259666A, Exp. MAR 2014; b) 259666B, Exp. MAR 2014