FDA-Drug2021-07-28Class I

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

Ummzy, LLC
Hazard

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.

Sold states
USA Nationwide
Affected count
163 boxes/10 capsules per box
Manufactured in
273 5th St, Unit A, Palisades Park, NJ, United States
Products
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2021

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