D-1145-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- July 21, 2017
- Termination Date
- March 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 bottles; 339 boxes
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
Distribution Pattern
Nationwide
Code Information
a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020