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.
Reported: July 8, 2015 Initiated: May 21, 2015 #D-1206-2015
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.
Details
- Recalling Firm
- Takeda Pharmaceuticals North America, Inc.
- Units Affected
- 3,619 bottles
- Distribution
- Nationwide
- Location
- Deerfield, IL
Frequently Asked Questions
What product 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.. Recalled by Takeda Pharmaceuticals North America, Inc.. Units affected: 3,619 bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 8, 2015. Severity: Moderate. Recall number: D-1206-2015.
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