Drug product
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
D-0562-2022
Product summary
- Firm
- ABC Sales 1 Inc
- Event
- Event 89558
- Status
- Terminated
- Classification
- Class I
- Quantity
- 565 cartons
- Official record key
drug-enforcement:D-0562-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Code information: Lot # 1230004, Exp. date 03/30/2024
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 tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.