Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Ton Shen Health Recalls Life Rising Brand “Side Head Regulator TT Tablet” Because of Possible Health Risk for Children Under the Age of 18

For Immediate Release

November 7, 2016

Contact

Consumers

1-312-842-2775

Announcement

Ton Shen Health of Chicago, IL, is recalling its Life Rising brand “Side Head Regulator TT” Tablets because they have tested positive for elevated levels of lead for children under the age of 18. Lead is 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. Lead poisoning can happen if a person is exposed to high levels of lead over short periods of time. Due to the test results affecting children and to the possibility of use by children, Ton Shen Health is recalling the TT product.

The recalled Life Rising brand "Side Head Regulator TT" tablets were mostly sold locally in Chicago area retail stores and some were distributed to other states through mail orders.

The product comes in a 1.6 ounce, white plastic package marked with lot # on the bottom. UPC: 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. 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.

If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. The extent of the functional detriment is dependent on the duration and degree of exposure. Such an outcome may occur if this product containing the reported level of lead were consumed by children in such a way. No illnesses have been reported to date in connection with this product, but the tablets have been tested and due to the elevated level of lead for children presently in TT samples tested, all TT products distributed by Ton Shen Health are being recalled.

The elevated lead level for children was noted after FDA tested a sample of TT tablets that were provided to the FDA. This recall is precautionary in nature, but important for all users of this product to comply with and make sure any TT products in their possession are not consumed by children and returned for a refund or destroyed.

The sale of the product has been suspended by Ton Shen Health effective end of September of 2016.

Consumers who have purchased Side Head Regulator TT tablets are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-312-842-2775 central standard time, Monday to Friday, from 9:30AM to 5:00PM.

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Product Photos

  • “Life Rising TT Side Head Regulator, Chinese Herbal Supplement, 60 Tablets 

Page Last Updated: 11/07/2016
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