Nuri Trading LLC: Drug Recall

Recall Details

Recall Number

D-0685-2021

Classification

Class I

Product Type

Drug

Recalling Firm

Nuri Trading LLC

Status

Ongoing

Date Initiated

03/29/2021

Location

Fort Lee, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

N/A

Reason for Recall

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Product Description

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Distribution Pattern

USA Nationwide

Other Recalls by Nuri Trading LLC

• Class I: Dangerous 03/29/2021
  Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
• Class I: Dangerous 03/29/2021
  Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
• Class I: Dangerous 03/29/2021
  Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

View all recalls by Nuri Trading LLC →