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

 
• By Ryan Nelson

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.

• Source: Alamy

The US Food and Drug Administration says drug firms that manufacture products using hydrocarbons, or that have changed raw material suppliers, should be mindful of the potential for benzene contamination, which has led to product recalls in the OTC drug and cosmetics sectors in 2021.

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