PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 20, 2017 Initiated: July 21, 2017 #D-1145-2017

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

Reason for Recall

Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil

Details

Recalling Firm
Chiavna Saffron LLC
Units Affected
211 bottles; 339 boxes
Distribution
Nationwide
Location
Huntersville, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Chiavna Saffron LLC. Units affected: 211 bottles; 339 boxes.
Why was this product recalled?
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Critical. Recall number: D-1145-2017.