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.
D-1099-2018
Product summary
- Event
- Event 80801
- Status
- Terminated
- Classification
- Class III
- Quantity
- 95,296 bottles
- Official record key
drug-enforcement:D-1099-2018
Official wording
Reason: Defective Container: Customer complaints of punctures in the bottle.
Code information: Lot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Container: Customer complaints of punctures in the bottle.