Drug product
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
D-1336-2022
Product summary
- Event
- Event 90551
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5,421 60-count bottles
- Official record key
drug-enforcement:D-1336-2022
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# 20212001, Exp. Date 12/2024
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.