Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead LevelsAUDIENCE: Consumer, Emergency Medicine ISSUE: FDA is investigating DHZC-2 tablets by Ton Shen Health/Life Rising for lead and other hazardous material and is also investigating to see if other Life Rising products from this company may be similarly affected. The products were mostly sold in the Chicago metropolitan area in stores and online. FDA collected product samples at the Ton Shen Health/Life Rising retail location in response to the initial adverse event report. FDA analysis confirmed that the samples contained 56 times the amount of lead above that which would pose a health risk for children according to the Provisional Total Tolerable Daily Intake (PTTDI). This finding prompted Ton Shen Health/Life Rising, on August 11, 2016, to initiate a recall of “DHZC-2” Tablets. After speaking with the FDA on August 25, 2016, Ton Shen Health/Life Rising agreed to expand its August 11, 2016 recall to include all lots of DHZC-2 tablets and cease distribution of all Life Rising products until September 1, 2016. FDA is reviewing regulatory options to remove all potentially unsafe Life Rising dietary supplement products from the market. FDA continues to investigate the DHZC-2 tablets for lead and other hazardous material and is also reviewing other Life Rising products at Ton Shen Health/Life Rising to see if they may be similarly affected. FDA will provide updated information as it becomes available. BACKGROUND: FDA was informed by the Cook County Department of Health (Illinois) of two children with elevated lead levels who may have consumed the recalled dietary supplement. In addition, FDA is also investigating reports of two fatalities of individuals who consumed this product. It is not clear if the deaths are associated with the product. RECOMMENDATION: Consumers should not purchase or consume recalled Life Rising brand dietary supplement DHZC-2 tablets from Ton Shen Health/Life Rising because they have been found to contain high levels of lead. FDA is also investigating to see if other Life Rising products from this company may be similarly affected. Consumers should not purchase or consume these products out of an abundance of caution. Contact your healthcare provider if you think you may have become ill from consuming the recalled tablets. Consumers with questions may contact the company at 1-312-842-2775, Monday to Friday, from 9:30AM to 5:00PM central standard time. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the FDA Outbreak notice, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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