A Chicago business whose supplement products have been recalled for expensive lead and linked to several illnesses and possibly two deaths of children is again recalling products because of excess lead content.
Ton Shen Health is recalling its Life Rising brand “Side Head Regulator TT”
tablets because of excessive lead, a naturally occurring element which can affect multiple body systems and is particularly harmful to young children.
“Recent lab tests indicate certain lots of TT product have elevated levels of lead above the currently recognized acceptable levels for children,” according to the recall notice on the Food and Drug Administration’s website.
The recalled Life Rising brand tablets were sold locally in Chicago area retail stores and distributed to other states through mail orders. The product comes in a 1.6 ounce, white plastic bottles marked a UPC number of 616042101010.
“People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output,” according to the recall notice.
“Children are particularly vulnerable to lead poisoning. Lead poisoning can be diagnosed through clinical testing, and individuals who have consumed TT Side Head Regulator should talk to their health care providers about testing.
No illnesses have been reported to date in connection with this product.
The sale of the product was suspended by Ton Shen Health effective at the end of September.
Previous problems ongoing
The recall of the “Side Head Regulator TT” tablets comes after Ton Shen Health/Life Rising recalled two other products because of elevated lead levels and adverse reactions among children.
“Consumers should not purchase or consume recalled Life Rising brand dietary supplement product DHZC-2 tablets or BRAIN-ECM capsules that have been collected and removed from the market because they have been found to contain high levels of lead. Consumers should not purchase or consume these products,” according to an FDA update posted in late October.
FDA continues to investigate a cluster of “five adverse events” related to the DHZC-2 tablets with the assistance of the Chicago and Cook County officials. Blood samples from three children have confirmed they have elevated lead levels.