Takeda Pharmaceuticals North America, Inc. recalls CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactur
Recalled July 8, 2015 · FDA recall D-1206-2015 · Takeda Pharmaceuticals North America
Hazard
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. · FDA Class II
Units
3,619 bottles
Sold at
Nationwide
Description
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Product
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.
Manufacturer(s)
Takeda Pharmaceuticals North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →