Drug product
UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
D-1036-2020
Product summary
- Event
- Event 84265
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,680 cartons
- Official record key
drug-enforcement:D-1036-2020
Official wording
Reason: Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Code information: All lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.