Exact FDA event identifier

Event 94853

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

Event summary

Timeline bucket: June 24, 2024
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Neilmed 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

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

D-0569-2024

Recall number: D-0569-2024
Initiated: June 24, 2024
Classification: Class III
Status: Ongoing
Recalling firm: Neilmed Pharmaceuticals Inc
Quantity: 20,370 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sub-potent Drug

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-potent Drug

Code information

Lot: SD134; Exp: 10/31/2026

Distribution pattern

Nationwide in the US