Exact FDA event identifier

Event 80801

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 09, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Orexigen Therapeutics, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-1099-2018
Initiated: August 09, 2018
Classification: Class III
Status: Terminated
Recalling firm: Orexigen Therapeutics, Inc.
Quantity: 95,296 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Customer complaints of punctures in the bottle.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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