PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: July 7, 2021 Initiated: April 8, 2021 #D-0641-2021

Product Description

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

Details

Recalling Firm
NSNY Distributor Inc
Units Affected
2600 capsules
Distribution
USA Nationwide
Location
Flushing, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by NSNY Distributor Inc. Units affected: 2600 capsules.
Why was this product recalled?
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Which agency issued this recall?
This recall was issued by the FDA Drug on July 7, 2021. Severity: Critical. Recall number: D-0641-2021.