FDA-Drug2015-07-08Class II
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.
Takeda Pharmaceuticals North America, Inc.
Hazard
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Sold states
Nationwide
Affected count
3,619 bottles
Manufactured in
One Takeda Parkway, Attn Supply Chain/Transportation, Deerfield, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1206-2015Don't want to check this manually?
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