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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
Recall Number D-1670-2012
Classification Class II
Code Info Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.
Product Distributed Qty 5311 bottles
Reason For Recall Microbial Contamination of Non Sterile Product; mold

Event Detail

Event Id 62779
Product Type Drugs
Status Ongoing
Recalling Firm Island Kinetics dba Covalence
City Chandler
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-13
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Atlanta, Georgia