FDA-Drug2022-02-23Class I
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
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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 in the USA via the internet through Amazon Marketplace.
Affected count
12,500 cartons
Manufactured in
14 Imperial Pl, N/A, Jackson, NJ, United States
Products
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0630-2022Don't want to check this manually?
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