FDA Recall D-0685-2021

Nuri Trading LLC · Fort Lee, NJ

Class I — life-threatening Ongoing 1872 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: all lots within expiry

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.

Recall record

Recall number: D-0685-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: USA Nationwide
Recall initiated: 2021-03-29
Classified by FDA Center: 2021-07-19
FDA published: 2021-07-28
Recalling firm: Nuri Trading LLC
Firm location: Fort Lee, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls