First, Methanol Plagued OTC Sanitizers, Now It's Valisure: Recommends Recalls Due To Benzene
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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The FDA offers insight into possible sources of benzene contamination in drug products, including aerosol spray propellants, carbomers, or other drug components made from hydrocarbons. Manufacturers that find benzene in drug product batches at levels exceeding 2 ppm should not release the product or, if already in distribution, discuss with the FDA initiating a voluntary recall.
“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.”
“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.