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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87609

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Namoo Enterprise 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

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

PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4

D-0351-2021
Recall number
D-0351-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Namoo Enterprise LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

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 tadalafil and sildenafil.

Code information

All lots within expiry

Distribution pattern

Nationwide within the United States