FDAClass IJuly 7, 2021

Premium OrgaZEN 7000 capsule recall

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

Why was Premium OrgaZEN 7000 capsule recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

all lots

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
Recalling firm
NSNY Distributor Inc
Quantity
2600 capsules
Distribution
USA Nationwide
Recall date
July 7, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls