Drug product
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
D-0638-2022
Product summary
- Firm
- Celebrate Today
- Event
- Event 89563
- Status
- Terminated
- Classification
- Class I
- Quantity
- 500 cartons
- Official record key
drug-enforcement:D-0638-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Code information: Lot # DK1027, Exp. 08/01/2023
Distribution pattern: Product was distributed nationwide in the USA via Amazon Marketplace
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.