FDA recall D-0563-2022

Product

MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.

Reason for recall

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

Distribution

Product was distributed nationwide in the USA via Amazon Marketplace.

Key facts

Status

Terminated

Initiation date

2022-02-08

Report date

2022-02-23

Termination date

2022-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monsey, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0563-2022