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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84279

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

Open FDA event record

Event summary

Timeline bucket
November 13, 2019
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Natures Rx

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

Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.

D-0633-2020
Recall number
D-0633-2020
Initiated
November 13, 2019
Classification
Class I
Status
Terminated
Recalling firm
Natures Rx
Quantity
2,800 capsules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

Code information

Lot # 01251ZX1, exp. date 11/2022 UPC: 610877392698

Distribution pattern

Nationwide in the U.S.