FDA recall D-0557-2022

Junp Hydration LLC · Class I · drug

Product

MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88

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 Amazon Marketplace

Key facts

Status: Terminated
Initiation date: 2022-02-04
Report date: 2022-02-16
Termination date: 2022-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2022