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.
To read the FDA update click here.
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