Drug product
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
D-1145-2017
Product summary
- Event
- Event 77812
- Status
- Terminated
- Classification
- Class I
- Quantity
- 211 bottles; 339 boxes
- Official record key
drug-enforcement:D-1145-2017
Official wording
Reason: Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Code information: a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil