Exact FDA event identifier

Event 95650

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

Event summary

Timeline bucket: October 29, 2024
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: VIONA PHARMACEUTICALS 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

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

D-0038-2025

Recall number: D-0038-2025
Initiated: October 29, 2024
Classification: Class II
Status: Ongoing
Recalling firm: VIONA PHARMACEUTICALS INC
Quantity: 6048 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Crystallization

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization

Code information

Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026

Distribution pattern

USA Nationwide