D-1350-2022 Class I Terminated
FDA drug recall D-1350-2022 was initiated by Ultra Supplement LLC on July 21, 2022 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. The recall status is terminated (terminated October 16, 2023). Affected quantity: 750 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- August 10, 2022
- Initiation Date
- July 21, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 750 cartons
Product Description
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Reason for Recall
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Distribution Pattern
Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
Code Information
Lot DAP272109, Exp: 4/1/2026