Medicine recalls
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| The United States: Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels |
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The Food and Drug Administration (FDA) announced that Ton Shen Health/Life Rising Corporation is expanding its recall of “DHZC-2” Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead. The recalled "DHZC-2" tablets were sold nationwide in retail stores and distributed through mail orders. The product comes in a 1.6 ounce bottle, UPC: 616042102727.
FDA is currently investigating 6 cases of adverse effects involving individuals taking DHZC-2 supplement tablets. The potential for contamination was noted after FDA notice of higher level of lead presence in DHZC-2 samples from lot #2163-844.
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 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm518482.htm
In Hong Kong, there is no registered pharmaceutical product with name DHZC-2. There is no registered pharmaceutical product manufactured or held by Ton Shen Health and no registered product with name Life Rising or held by Life Rising. Related news on recall of DHZC-2 tablets was previously issued by the US FDA, and was posted on the Drug Office website on 13 August 2016.
Ends/ Wednesday, August 31, 2016
Issued at HKT 13:00
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