Exact FDA event identifier

Event 81505

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

Event summary

Timeline bucket: October 05, 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, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99

D-0219-2019

Recall number: D-0219-2019
Initiated: October 05, 2018
Classification: Class III
Status: Terminated
Recalling firm: Orexigen Therapeutics, Inc.
Quantity: 18,895 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

packaging defect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Container packaging defect.

Code information

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

Distribution pattern

Within the United States