Contrave Tablet, Extended Release
FDA Recall NDC 51267-890
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Contrave (NDC 51267-890). A significant event, classified as Class III, was initiated on Oct 05, 2018 by Nalpropion Pharmaceuticals Llc. The reported reason for this action was: "Container packaging defect."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Container packaging defect.
Oct 05, 2018
Nov 14, 2018
18,895 bottles
Recall Profile & Regulatory Data
Event ID
81505
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Orexigen Therapeutics, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the United States
Termination Date
Nov 15, 2019
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
Batch or Lot Expiration Information
Lot# : ZYCY, Exp. 04/11/2021
Affected Packages Involved in this Recall
51267-890-99Product
51267-890-07Product
Class III Terminated
Defective Container: Customer complaints of punctures in the bottle.
Aug 09, 2018
Aug 22, 2018
95,296 bottles
Recall Profile & Regulatory Data
Event ID
80801
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Orexigen Therapeutics, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 15, 2019
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.
Batch or Lot Expiration Information
Lot# : ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Affected Packages Involved in this Recall
51267-890-99Product
51267-890-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
