D-1206-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2015
- Initiation Date
- May 21, 2015
- Termination Date
- February 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,619 bottles
Product Description
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Distribution Pattern
Nationwide
Code Information
Lot # B21642; Exp. 03/17