Exact FDA event identifier

Event 70041

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

Event summary

Timeline bucket: December 09, 2014
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Akorn, 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

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

D-0333-2015

Recall number: D-0333-2015
Initiated: December 09, 2014
Classification: Class III
Status: Terminated
Recalling firm: Akorn, Inc.
Quantity: 3,937 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Code information

Lots 1413900, 1417200, 1417300, Exp. 02/15

Distribution pattern

Nationwide