PlainRecalls
FDA Drug Moderate Class II Terminated

Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.

Reported: May 26, 2021 Initiated: March 24, 2021 #D-0388-2021

Product Description

Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.

Reason for Recall

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

Details

Recalling Firm
Bit & Bet LLC
Units Affected
3894 ten-count boxes (38,940 capsules)
Distribution
Nationwide
Location
Cliffside Park, NJ

Frequently Asked Questions

What product was recalled?
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.. Recalled by Bit & Bet LLC. Units affected: 3894 ten-count boxes (38,940 capsules).
Why was this product recalled?
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0388-2021.