FDA recall D-1338-2022

Product

Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Distribution

The product was distributed nationwide in the USA and Canada.

Key facts

Status

Terminated

Initiation date

2022-06-27

Report date

2022-07-27

Termination date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1338-2022