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Champaklal Maganlal Homeo Pharmacy Private Limited and related importers were cited for manufacturing and distributing unapproved new drugs "Bebelyn Diarrhea" and "Bebelyn Colic" without FDA approval in violation of the Federal Food, Drug, and Cosmetic Act. The company failed to conduct adequate identity testing of glycerin, a high-risk component used in drug manufacturing, creating significant contamination risks with toxic substances like diethylene glycol and ethylene glycol. These violations were particularly concerning because the products were formulated and labeled for use in infants and children as young as 3 months old, raising serious public health safety issues given the known lethal effects of glycerin contamination documented worldwide.