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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 XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
Recall Number D-1340-2014
Classification Class I
Code Info Lot 130520PL Exp. 05/31/2017
Product Distributed Qty 89 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