FDA recall D-343-2014

Boehringer Ingelheim Roxane Inc · Class III · 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

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

Key facts

Status: Terminated
Initiation date: 2013-03-18
Report date: 2013-12-18
Termination date: 2014-02-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-343-2014