Drug product
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
D-1338-2022
Product summary
- Event
- Event 90551
- Status
- Terminated
- Classification
- Class I
- Quantity
- 500 4-count tins
- Official record key
drug-enforcement:D-1338-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product 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 # 2022104, exp. date 04/2025
Distribution pattern: The product was distributed nationwide in the USA and Canada.
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.