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Recall Observatory FDA recall evidence

Drug 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.

D-1099-2018

August 09, 2018

Class III

Product summary

Firm
Orexigen Therapeutics, Inc.
Event
Event 80801
Status
Terminated
Classification
Class III
Quantity
95,296 bottles
Official record key
drug-enforcement:D-1099-2018

Official wording

Reason: Defective Container: Customer complaints of punctures in the bottle.

Code information: Lot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Customer complaints of punctures in the bottle.