FDA recall D-0638-2022

Product

RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.

Reason for recall

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

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

2022-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brentwood, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0638-2022