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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87981

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 18, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Miracle 8989

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

3 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 3

PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

D-0633-2021
Recall number
D-0633-2021
Initiated
May 18, 2021
Classification
Class I
Status
Terminated
Recalling firm
Miracle 8989
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Code information

All lots remaining within expiry.

Distribution pattern

USA Nationwide

drug · product 2 of 3

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

D-0634-2021
Recall number
D-0634-2021
Initiated
May 18, 2021
Classification
Class I
Status
Terminated
Recalling firm
Miracle 8989
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Code information

All lots remaining within expiry.

Distribution pattern

USA Nationwide

drug · product 3 of 3

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028

D-0635-2021
Recall number
D-0635-2021
Initiated
May 18, 2021
Classification
Class I
Status
Terminated
Recalling firm
Miracle 8989
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Code information

All lots remaining within expiry.

Distribution pattern

USA Nationwide