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Class III: unlikely to cause harmTerminated

Orexigen Therapeutics Contrave Recall

Contrave (naltrexone HCl and bupropion HCl)

Orexigen Therapeutics, Inc. · La Jolla, CA

Risk level
Class III
Reported by FDA
Nov 14, 2018
Recall ID
D-0219-2019
Check your lot numberHow we source this data

Summary

Orexigen Therapeutics recalled Contrave starting Oct 5, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0219-2019 on Nov 14, 2018. Reason: Container packaging defect. Status: Terminated.

Why it was recalled

Container packaging defect.

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: ZYCY, Exp. 04/11/2021

Where it was sold

Within the United States

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-0219-2019
Classification
Class III
Status
Terminated
Recall initiated
Oct 5, 2018
FDA report date
Nov 14, 2018
Quantity
18,895 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Orexigen Therapeutics, Inc.

Original FDA data

Every field from FDA enforcement report D-0219-2019, exactly as published.

Show all FDA fields
City
La Jolla
State
CA
Status
Terminated
Country
United States
Event ID
81505
Address
3344 N Torrey Pines Ct Ste 200
Code information
Lot #: ZYCY, Exp. 04/11/2021
Postal code
92037-1024
Report date
Nov 14, 2018
Product type
Drugs
Recall number
D-0219-2019
Classification
Class III
Recalling firm
Orexigen Therapeutics, Inc.
Product quantity
18,895 bottles
Termination date
Nov 15, 2019
Reason for recall
Container packaging defect.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Within the United States
Recall initiation date
Oct 5, 2018
Initial firm notification
Letter
Center classification date
Nov 6, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0219-2019, published Nov 14, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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