Boehringer Ingelheim Roxane Inc recalls Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count
Recalled 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
Hazard / Issue
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Issued by
FDA
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