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
Product summary
- 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
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.