FDA recall D-0370-2021

QMart · Class II · drug

Product

Burro en Primavera, 2 capsules, UPC 638632431055

Reason for recall

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2021-03-31
Report date
2021-05-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0370-2021