Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead

AUDIENCE: Consumer, Pediatrics

ISSUE: 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.

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.

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.

BACKGROUND: 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. See the press release for product photo.

RECOMMENDATION: 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.

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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm528315.htm