FDA recall D-0630-2022

Product

THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was 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

Product was distributed nationwide in the USA via the internet through 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

Jackson, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0630-2022