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First, Methanol Plagued OTC Sanitizers, Now It's Valisure: Recommends Recalls Due To Benzene

Executive Summary

FDA should recall dozens of hand sanitizers found to contain benzene, a known human carcinogen, says Valisure, the compounding pharmacy that raised initial alarm about ranitidine in OTC heartburn drugs, leading eventually to withdrawals of the products.

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‘Valisure Scenario’ Plan Should Be Ready In Consumer Health, Personal Care Firms’ Tool Kits

“What started a couple years ago with the discovery of nitrosamine in blood pressure and heart medicine has since evolved to benzene in hand sanitizer and sunscreen,” says Sedgwick International’s Amanda Combs about “Valisure scenario.”

With 'No Transparency To Drug Quality' In US, Requiring Independent Testing Needed – Valisure

“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that the FDA actually tests anything. It's all self-reported testing, by manufacturers that are also selling the product,” says Valisure CEO David Light.

Valisure’s Benzene Testing Finds Problems With OTC Sunscreens, Cosmetic Sun Care Products

Independent lab's analysis found benzene levels at “up to three times the conditionally restricted FDA concentration limit of 2 ppm" in 10 Neutrogena sunscreen formulations.

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