FDA recall D-0688-2021

Product

69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC

Reason for recall

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.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2021-03-29

Report date

2021-07-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Lee, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0688-2021