Why it was recalled
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Product description
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
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-0663-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 30, 2021
- FDA report date
- Jul 28, 2021
- Quantity
- 364 boxes/10 capsules per box
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ummzy, LLC
Original FDA data
Every field from FDA enforcement report D-0663-2021, exactly as published.
Show all FDA fields
- City
- Palisades Park
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87624
- Address
- 273 5th St
- Address (line 2)
- Unit A
- Code information
- All lots within expiry.
- Postal code
- 07650-2088
- Report date
- Jul 28, 2021
- Product type
- Drugs
- Recall number
- D-0663-2021
- Classification
- Class I
- Recalling firm
- Ummzy, LLC
- Product quantity
- 364 boxes/10 capsules per box
- Termination date
- Jun 9, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 30, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jul 16, 2021