PlainRecalls
FDA Drug Critical Class I Terminated

Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.

Reported: July 28, 2021 Initiated: March 30, 2021 #D-0664-2021

Product Description

Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.

Reason for Recall

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Details

Recalling Firm
Ummzy, LLC
Units Affected
163 boxes/10 capsules per box
Distribution
USA Nationwide
Location
Palisades Park, NJ

Frequently Asked Questions

What product was recalled?
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.. Recalled by Ummzy, LLC. Units affected: 163 boxes/10 capsules per box.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0664-2021.