FDAClass IISeptember 5, 2012

CosMedix Serious Protection recall: Mold

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.

Why was CosMedix Serious Protection recalled?

Microbial Contamination of Non Sterile Product; mold

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch # P030911C, Exp 03/13; Batch # P022811A, Exp 02/13.

Product
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.
Recalling firm
Island Kinetics dba Covalence
Quantity
5311 bottles
Distribution
Atlanta, Georgia
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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