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.
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The agency is calling for an ISO 17025-accredited or equivalent partner to screen selected drug products for benzene, following a rash of sunscreen, antiperspirant and other OTC drug product recalls which triggered a rush on testing laboratories, as well as class action filings across the US.
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