Product: 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.
Recall initiated: 20220721
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated