Safety

Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

UPDATED 08/30/2016. 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.

[Posted 08/29/2016]

AUDIENCE: 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/30/2016 - Press Release - Ton Shen Health]
[08/25/2016 - Outbreak Investigation - FDA]

Previous MedWatch Alert:

[08/12/2016 - DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk]
 

Page Last Updated: 08/30/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English