Exact FDA event identifier

Event 92089

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

Event summary

Timeline bucket: April 01, 2022
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Wellness BioSciences

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

CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx

D-0541-2023

Recall number: D-0541-2023
Initiated: April 01, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Wellness BioSciences
Quantity: 2000 inhalers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA

Code information

All lots

Distribution pattern

Nationwide within the United States