Drug product
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
D-0470-2018
Product summary
- Event
- Event 78643
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10 boxes
- Official record key
drug-enforcement:D-0470-2018
Official wording
Reason: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Code information: All lots within expiry.
Distribution pattern: Product was distributed in the United States.
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.