FDAMay 21, 2015drug
CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
What to do
FDA enforcement status: Terminated
Brands named
takeda pharmaceuticals north americatakedatakeda pharmaceuticals
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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