Exact FDA event identifier

Event 91150

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

Event summary

Timeline bucket: November 14, 2022
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 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60

D-0074-2023

Recall number: D-0074-2023
Initiated: November 14, 2022
Classification: Class III
Status: Terminated
Recalling firm: Acella Pharmaceuticals, LLC
Quantity: 528 cartons

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: Out of specification for assay at the end-of-shelf-life 24-month period.

Code information

Lot#: 21084, 21085, Exp 06/30/2023

Distribution pattern

USA Nationwide