FDA recall D-1099-2018

Orexigen Therapeutics, Inc. · Class III · drug

Product

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

Reason for recall

Defective Container: Customer complaints of punctures in the bottle.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-08-09
Report date
2018-08-22
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-1099-2018