Boehringer Ingelheim Roxane Inc recalls Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054

Recalled December 18, 2013 · FDA recall D-343-2014 · Boehringer Ingelheim Roxane

Hazard

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets. · FDA Class III

Units

8,550 cartons and bottles

Sold at

Nationwide and Puerto Rico

Description

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

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

Manufacturer(s)

Boehringer Ingelheim Roxane Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →