Positive Health recalls RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Recalled March 2, 2022 · FDA recall D-0645-2022 · Positive Health
Hazard
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. · FDA Class I
Units
5,500 cartons
Sold at
Product was distributed nationwide via the internet through Amazon Marketplace.
Description
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.
Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Manufacturer(s)
Positive Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →