FDA recall D-0219-2019

Orexigen Therapeutics, Inc. · Class III · drug

Product

Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99

Reason for recall

Container packaging defect.

Distribution

Within the United States

Key facts

Status: Terminated
Initiation date: 2018-10-05
Report date: 2018-11-14
Termination date: 2019-11-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Jolla, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2019