PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: June 30, 2021 Initiated: May 18, 2021 #D-0633-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Miracle 8989
Units Affected
Unknown
Distribution
USA Nationwide
Location
Dallas, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Miracle 8989. Units affected: Unknown.
Why was this product recalled?
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 30, 2021. Severity: Critical. Recall number: D-0633-2021.