October 2018 FDA Recall Contrave by Orexigen Therapeutics, Inc.
D-0219-2019 - Container packaging defect.
This Class III drug recall was voluntarily initiated by Orexigen Therapeutics, Inc. on October 5, 2018 for the product Contrave. The FDA reported the reason for recall as container packaging defect.. The product was distributed in Within the United States and the recall is currently terminated.
Recall Number: D-0219-2019
Container packaging defect.
10-05-2018
11-14-2018
18,895 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Orexigen Therapeutics, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Within the United States
11-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
