Hand Sanitizer Problems Prompt US FDA Guidance On Keeping Methanol Out Of Other OTC Drugs
Final guidance, for pharmaceutical alcohol used as an active or inactive ingredient in other drugs as well as hand sanitizers, “will help pharmaceutical manufacturers avoid using pharmaceutical alcohol contaminated with or substituted with methanol in drug products.”
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More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.