Ultra Supplement LLC: Drug Recall

Recall #D-1350-2022 · 07/21/2022

Class I: Dangerous

Recall Details

Recall Number
D-1350-2022
Classification
Class I
Product Type
Drug
Recalling Firm
Ultra Supplement LLC
Status
Terminated
Date Initiated
07/21/2022
Location
Wilmington, DE, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
750 cartons

Reason for Recall

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

Product Description

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.