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Recall Observatory FDA recall evidence

Drug 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

D-0219-2019

October 05, 2018

Class III

Product summary

Firm
Orexigen Therapeutics, Inc.
Event
Event 81505
Status
Terminated
Classification
Class III
Quantity
18,895 bottles
Official record key
drug-enforcement:D-0219-2019

Official wording

Reason: Container packaging defect.

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

Distribution pattern: Within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging defect