FDA recall D-1350-2022

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.

Distribution

Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.

Key facts

Status

Terminated

Initiation date

2022-07-21

Report date

2022-08-10

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2022