July 2022 FDA Recall Drug by Ultra Supplement Llc
D-1350-2022 - Marketed Without an Approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Ultra Supplement Llc on July 21, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1350-2022
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
07-21-2022
08-10-2022
750 cartons
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ultra Supplement LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
10-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Batch or Lot Expiration Information
Lot# Lot DAP272109, Exp: 4/1/2026
