PlainRecalls
FDA Drug Critical Class I Ongoing

Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Reported: July 28, 2021 Initiated: March 29, 2021 #D-0686-2021

Product Description

Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Reason for Recall

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.

Details

Recalling Firm
Nuri Trading LLC
Units Affected
N/A
Distribution
USA Nationwide
Location
Fort Lee, NJ

Frequently Asked Questions

What product was recalled?
Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC. Recalled by Nuri Trading LLC. Units affected: N/A.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0686-2021.