FDA-Drug2022-03-02Class I
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
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.
Sold states
Product was distributed nationwide via the internet through Amazon Marketplace.
Affected count
5,500 cartons
Manufactured in
1013 Centre Rd, Suite 403B, Wilmington, DE, United States
Products
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2022Don't want to check this manually?
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