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- 09 Aug 2017, 16:22
#2262
This product is sold online and manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. Individuals have also mailed or brought the product into the United States. “Balguti Kesaria Ayurvedic Medicine” is used with infants and children for a variety of conditions including rickets, cough and cold, worms and dentition (teething).
FDA initially learned of this risk from the North Carolina Division of Public Health after the product was tested and found to contain high levels of lead. FDA was also notified by the Michigan Department of Health and Human Services of high levels of lead in two children who were given this product. Michigan’s testing also found high levels of lead in the product. To date, FDA has received one adverse event report of high levels of lead and developmental delays in a child who was given this product.
FDA initially learned of this risk from the North Carolina Division of Public Health after the product was tested and found to contain high levels of lead. FDA was also notified by the Michigan Department of Health and Human Services of high levels of lead in two children who were given this product. Michigan’s testing also found high levels of lead in the product. To date, FDA has received one adverse event report of high levels of lead and developmental delays in a child who was given this product.
