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Recall Observatory FDA recall evidence

Drug product

THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.

D-0630-2022

February 08, 2022

Class I

Product summary

Firm
Your Favorite Shop
Event
Event 89579
Status
Terminated
Classification
Class I
Quantity
12,500 cartons
Official record key
drug-enforcement:D-0630-2022

Official wording

Reason: 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.

Code information: Lot # 26436989, Exp. date 10/30/2023

Distribution pattern: Product was distributed nationwide in the USA via the internet through Amazon Marketplace.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.