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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82401

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

Open FDA event record

Event summary

Timeline bucket
March 18, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ingenus Pharmaceuticals Llc

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

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

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

D-1058-2019
Recall number
D-1058-2019
Initiated
March 18, 2019
Classification
Class III
Status
Terminated
Quantity
29,435 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Code information

Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020

Distribution pattern

Nationwide in the USA and Puerto Rico.