CLASS II ONGOING Drug recall · Reported 5 May 2021 · FDA Enforcement Report

PremierZen Platinum recalled by Na Na Collection

Na Na Collection is recalling PremierZen Platinum 5000, distributed nationwide in the US. The recall was initiated on 30 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0353-2021
FDA event ID
87653
Recalling firm
Na Na Collection, Elmwood Park, NJ
Classification
Class II
Status
Ongoing
Recall initiated
30 Mar 2021
FDA classified
26 Apr 2021
Reported
5 May 2021
Type
Voluntary: Firm initiated
Customers notified by
Press Release

Timeline

30 Mar 2021Recall initiated by company
26 Apr 2021Classified by FDA+27 days
5 May 2021Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006

Where it was distributed

Nationwide with the United States

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856

Where was it sold?

Nationwide with the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 87653

This product is part of a recall event; the main page for the event is Triple SupremeZen Gold recalled by Na Na Collection.

ReportedClassRecallCompanyReasonWhere
CLASS IITriple SupremeZen Gold recalled by Na Na CollectionNa Na CollectionHidden Drug IngredientsNationwide

More recalls from Na Na Collection

All 2
ReportedClassRecallCompanyReasonWhere
DrugCLASS IITriple SupremeZen Gold recalled by Na Na CollectionNa Na CollectionHidden Drug IngredientsNationwide