FDA recall D-0562-2022

Product

MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.

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-0562-2022