Home / Recalls / Ummzy, LLC / D-0664-2021

D-0664-2021 Class I Terminated

Recalled by Ummzy, LLC — Palisades Park, NJ

Recall Details

Product Type
Drugs
Report Date
July 28, 2021
Initiation Date
March 30, 2021
Termination Date
June 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
163 boxes/10 capsules per box

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.

Distribution Pattern

USA Nationwide

Code Information

All lots within expiry.

Other recalls by Ummzy, LLC

  • D-0663-2021 Class I — Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made (March 30, 2021)
  • D-0662-2021 Class I — Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count box (March 30, 2021)