Why it was recalled
Defective Container: Customer complaints of punctures in the bottle.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1099-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 9, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 95,296 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Orexigen Therapeutics, Inc.
Original FDA data
Every field from FDA enforcement report D-1099-2018, exactly as published.
Show all FDA fields
- City
- La Jolla
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80801
- Address
- 3344 N Torrey Pines Ct Ste 200
- Code information
- Lot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
- Postal code
- 92037-1024
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1099-2018
- Classification
- Class III
- Recalling firm
- Orexigen Therapeutics, Inc.
- Product quantity
- 95,296 bottles
- Termination date
- Nov 15, 2019
- Reason for recall
- Defective Container: Customer complaints of punctures in the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2018