Exact FDA event identifier

Event 83501

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

Event summary

Timeline bucket: July 29, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Upsher Smith Laboratories, 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

Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00

D-1836-2019

Recall number: D-1836-2019
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: Upsher Smith Laboratories, Inc.
Quantity: 166 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot: A2610. exp 3/2020

Distribution pattern

KY, OH, NJ, LA