Why it was 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.
Product description
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Lot numbers, UPCs & expiration codes
all lots within expiry
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0688-2021
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 29, 2021
- FDA report date
- Jul 28, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nuri Trading LLC
Original FDA data
Every field from FDA enforcement report D-0688-2021, exactly as published.
Show all FDA fields
- City
- Fort Lee
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87641
- Address
- 800 Palisade Ave
- Code information
- all lots within expiry
- Postal code
- 07024-4193
- Report date
- Jul 28, 2021
- Product type
- Drugs
- Recall number
- D-0688-2021
- Classification
- Class I
- Recalling firm
- Nuri Trading LLC
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 29, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jul 19, 2021