Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Product description
SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
Lot numbers, UPCs & expiration codes
Lot: 48656, Exp. 01/2025
Where it was sold
Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela
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-1333-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 22, 2022
- FDA report date
- Aug 10, 2022
- Quantity
- 2000 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Distributor RFR, LLC.
Original FDA data
Every field from FDA enforcement report D-1333-2022, exactly as published.
Show all FDA fields
- City
- Doral
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 90675
- Address
- 3580 Nw 85th Ct Apt 150
- Code information
- Lot: 48656, Exp. 01/2025
- Postal code
- 33122-1986
- Report date
- Aug 10, 2022
- Product type
- Drugs
- Recall number
- D-1333-2022
- Classification
- Class I
- Recalling firm
- Distributor RFR, LLC.
- Product quantity
- 2000 cartons
- Termination date
- Jul 29, 2025
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
- Distribution pattern
- Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela
- Recall initiation date
- Jul 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2022