August 2018 FDA Recall Contrave by Orexigen Therapeutics, Inc.
D-1099-2018 - Defective Container
This Class III drug recall was voluntarily initiated by Orexigen Therapeutics, Inc. on August 9, 2018 for the product Contrave. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1099-2018
Defective Container: Customer complaints of punctures in the bottle.
08-09-2018
08-22-2018
95,296 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.
Nationwide in the USA
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, 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
