Why it was recalled
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Product description
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Lot numbers, UPCs & expiration codes
a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020
Where it was sold
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-1145-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 21, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 211 bottles; 339 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chiavna Saffron LLC
Original FDA data
Every field from FDA enforcement report D-1145-2017, exactly as published.
Show all FDA fields
- City
- Huntersville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 77812
- Address
- 14235 Boren St
- Address (line 2)
- Apt 201
- Code information
- a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020
- Postal code
- 28078-6516
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1145-2017
- Classification
- Class I
- Recalling firm
- Chiavna Saffron LLC
- Product quantity
- 211 bottles; 339 boxes
- Termination date
- Mar 27, 2018
- Reason for recall
- Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 21, 2017
- Initial firm notification
- Press Release
- Center classification date
- Sep 12, 2017