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US FDA Advises Drug Firms To Test For Benzene Contamination As Root-Cause Investigation Continues

Executive Summary

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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