Exact FDA event identifier

Event 94485

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

Event summary

Timeline bucket: April 24, 2024
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Acella 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

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

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

D-0490-2024

Recall number: D-0490-2024
Initiated: April 24, 2024
Classification: Class III
Status: Terminated
Recalling firm: Acella Pharmaceuticals, LLC
Quantity: 7104 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot # 22085 Exp. date 08/02/2024

Distribution pattern

Nationwide in the US and Puerto Rico.