Two people have died who had the product but it is unclear if it caused or contributed to their deaths.
A cluster of six ‘adverse events’ have been associated with Life Rising dietary supplements from Ton Shen Health/Life Rising.
An 'adverse event' is any undesirable experience associated with the use of a medical product in a patient.
Three reports involve children who may have had the dietary supplement.
Ton Shen Health/Life Rising has expanded an earlier recall to include all lots of DHZC-2 tablets and ceased distribution of all Life Rising products until the start of September. It is unclear if production has now resumed but the investigation is ongoing.
56 times lead amount above level which poses a risk for children
The FDA collected product samples from Ton Shen Health/Life Rising. Analysis confirmed they contained 56 times the amount of lead above which would pose a health risk for children.
This prompted Ton Shen Health/Life Rising to recall one lot of DHZC-2 Tablets on August 11.
The Blood Circulation Regulator product is imported from China and was added to an FDA import alert on August 25.
The agency used an Inductively Coupled Plasma Mass Spectrometer (ICP-MS) which can detect lead down to the parts-per-billion (ppb) level. This instrument and methodology is used for testing dietary supplements for lead and other toxic elements.
FDA said it was investigating to see if other Life Rising products may be affected.
The agency advised retailers to contact any customers that have bought the recalled products in the last 36 months and inform them of the recall.
To be conservative and as a precaution, FDA recommended the 36 month timeframe as an estimate to protect public health. It is reasonable that after 36 months consumers would have taken or discarded the product.
It comes in a 1.6 ounce, white plastic package. The UPC code 616042102727 can be found on all recalled DHZC-2 bottles and were sold nationwide in stores and online.
Further investigation
The Cook County Department of Health (Illinois) and the City of Chicago are also investigating elevated lead levels linked to the herbal supplement.
Small exposure to lead does not pose a significant public health concern. However, exposure to larger amounts can cause lead poisoning.
Nirav D. Shah, IDPH director, said lead poisoning can occur when a person is exposed to high levels over a short period of time.
“We urge people not buy the recalled supplement if they see it in stores, and for people who have purchased this product, to return it for a refund. The health effects of lead poisoning can be serious, and in some cases deadly.”
The Illinois Department of Public Health (IDPH) said it was aware of two illnesses associated with this supplement as well as the possibility of two deaths.