PlainRecalls
FDA Drug Critical Class I Terminated

MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.

Reported: May 28, 2014 Initiated: January 9, 2014 #D-1337-2014

Product Description

MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.

Reason for Recall

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Details

Units Affected
49 blister packs
Distribution
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Location
Nixa, MO

Frequently Asked Questions

What product was recalled?
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.. Recalled by Schindele Enterprises dba Midwest Wholesale. Units affected: 49 blister packs.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2014. Severity: Critical. Recall number: D-1337-2014.