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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82419

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

Open FDA event record

Event summary

Timeline bucket
March 14, 2019
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Ata International 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

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

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0

D-1085-2019
Recall number
D-1085-2019
Initiated
March 14, 2019
Classification
Class I
Status
Terminated
Recalling firm
Ata International Inc
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

Code information

All lots

Distribution pattern

Nationwide within the United States