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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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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
Distribution Pattern Atlanta, Georgia

Product Detail

Product Description Product Type Code Info Classification Reason for Recall Product Quantity Recall Number
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. Drugs Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13. Class II Microbial Contamination of Non Sterile Product; mold 5311 bottles D-1670-2012