FDA recall D-0641-2021

NSNY Distributor Inc · Class I · drug

Product

Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2021-04-08
Report date
2021-07-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Flushing, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0641-2021