Drug product
Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783
D-1037-2020
Product summary
- Event
- Event 84265
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1880 cartons
- Official record key
drug-enforcement:D-1037-2020
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.