Recalls / Class III
Class IIID-1099-2018
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.
- 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 #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Why it was recalled
Defective Container: Customer complaints of punctures in the bottle.
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
- 95,296 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-09
- FDA classified
- 2018-08-16
- Posted by FDA
- 2018-08-22
- Terminated
- 2019-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1099-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.