FDA recall D-1337-2014

Schindele Enterprises dba Midwest Wholesale · Class I · drug

Product

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.

Distribution

Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

Key facts

Status
Terminated
Initiation date
2014-01-09
Report date
2014-05-28
Termination date
2015-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nixa, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1337-2014