FDA-Drug2013-12-18Class III
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
Boehringer Ingelheim Roxane Inc
Hazard
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Sold states
Nationwide and Puerto Rico
Affected count
8,550 cartons and bottles
Manufactured in
1809 Wilson Rd, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-343-2014Don't want to check this manually?
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