Drug & medication recalls Moderate risk

Takeda Pharmaceuticals North America, Inc. recalls CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactu…

Recall date
May 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1206-2015
FDA classification
Class II
Brand / firm
Takeda Pharmaceuticals North America, Inc.
Sold / distributed
Nationwide

Why it was recalled

Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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