Exact FDA event identifier

Event 87630

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

Event summary

Timeline bucket: March 24, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bit & Bet 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

Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.

D-0388-2021

Recall number: D-0388-2021
Initiated: March 24, 2021
Classification: Class II
Status: Terminated
Recalling firm: Bit & Bet LLC
Quantity: 3894 ten-count boxes (38,940 capsules)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.

Code information

All lots within expiry.

Distribution pattern

Nationwide