FDA recall D-0311-2021

Product

Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-02-15

Report date

2021-03-31

Termination date

2022-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairview, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0311-2021