Recalls / Class III
Class IIID-0219-2019
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
- Brand name
- Contrave
- Generic name
- Naltrexone Hydrochloride And Bupropion Hydrochloride
- Active ingredients
- Bupropion Hydrochloride, Naltrexone Hydrochloride
- Route
- Oral
- NDC
- 51267-890
- FDA application
- NDA200063
- Affected lot / code info
- Lot #: ZYCY, Exp. 04/11/2021
Why it was recalled
Container packaging defect.
Recalling firm
- Firm
- Orexigen Therapeutics, Inc.
- Manufacturer
- Nalpropion Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3344 N Torrey Pines Ct Ste 200, La Jolla, California 92037-1024
Distribution
- Quantity
- 18,895 bottles
- Distribution pattern
- Within the United States
Timeline
- Recall initiated
- 2018-10-05
- FDA classified
- 2018-11-06
- Posted by FDA
- 2018-11-14
- Terminated
- 2019-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0219-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.