FDA recall D-1145-2017

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-21

Report date

2017-09-20

Termination date

2018-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntersville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1145-2017