Drug product
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
D-1350-2022
Product summary
- Event
- Event 90659
- Status
- Terminated
- Classification
- Class I
- Quantity
- 750 cartons
- Official record key
drug-enforcement:D-1350-2022
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Code information: Lot DAP272109, Exp: 4/1/2026
Distribution pattern: Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.