FDA recall D-0645-2022

Positive Health · Class I · drug

Product

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

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 via the internet through Amazon Marketplace.

Key facts

Status: Terminated
Initiation date: 2022-02-10
Report date: 2022-03-02
Termination date: 2022-06-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2022