FDA recall D-0388-2021

Product

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-03-24

Report date

2021-05-26

Termination date

2021-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cliffside Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2021