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.
You may also be interested in...
US Petition Claims Benzene Forms In Benzoyl Peroxide, Requests Market Removal Of Acne Drugs
Valisure recommends FDA request recall and halt sales of products containing benzoyl peroxide due to its propensity to form the benzene. Products include numerous OTC monograph topical formulations as well Rx drugs with an acne indication available through approved applications.
US FDA Recommends Tests, Documentation To Show Benzene No Higher Than 2PPM In Drugs
CDER says guidance needed to help facilitate and expedite reformulating drug products which use carbomers manufactured with benzene, a human carcinogen, so that no more than 2 parts per million of the substance is present.
US FDA Advises Drug Firms To Test For Benzene Contamination As Root-Cause Investigation Continues
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.