FDAClass IJuly 28, 2021

69MODE Blue 69 capsule recall

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

Why was 69MODE Blue 69 capsule recalled?

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.

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 within expiry

Product
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Recalling firm
Nuri Trading LLC
Quantity
N/A
Distribution
USA Nationwide
Recall date
July 28, 2021
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls