The US Food and Drug Administration (FDA) warns consumers and caregivers not to use Eu Yan Sang (Hong Kong) Ltd.'s "Bo Ying compound" because of the possible lead poisoning risk associated with the product. This reminder comes after the Maryland Department of Health and Mental Hygiene found elevated levels of lead in these products.
The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.
Parents and caregivers are advised to not purchase or use "Bo Ying compound." Anyone using this product or providing it to a child should immediately consult a healthcare professional.
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.
FDA has received one adverse event of lead poisoning in an 18-month-old child who was given this product. HEALTH is not aware of any additional cases of lead poisoning associated with the products.
Healthcare professionals and consumers are encouraged to report any adverse events potentially related to "Bo Ying compound" manufactured by Eu Yan Sang (Hong Kong) Ltd. or to any other alternative medicines to FDA's MedWatch Adverse Event Reporting program by: * Completing and submitting the report online at MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/) * Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178
FDA became aware of the lead poisoning risk associated with "Bo Ying compound" products last fall from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has an import alert in place that includes Eu Yan Sang (Hong Kong) Ltd. and the product "Bo Ying compound" (http://www.accessdata.fda.gov/cms_ia/importalert_190.html). The import alert is intended to prevent the product from entering the United States.
More information from FDA is available at http://www.fda.gov/drugs/drugsafety/ucm416220.htm
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