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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Recall Number D-1337-2014
Classification Class I
Code Info 1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.
Product Distributed Qty 49 blister packs
Reason For Recall Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Event Detail

Event Id 67228
Product Type Drugs
Status Ongoing
Recalling Firm Schindele Enterprises dba Midwest Wholesale
City Nixa
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-09
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI