FDA MedWatch - DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

AUDIENCE: Consumer

ISSUE: Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.One illness has been reported to date in connection with this problem.

BACKGROUND: The recalled "DHZC-2" tablets were mostly sold locally in Chicago area in retails 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 # 2163-844 on the bottom. UPC: 616042102727. The potential for contamination was noted after FDA notice of higher level of lead presence in DHZC-2 samples. The sale of the product has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem.

RECOMMENDATION: Consumers who have purchased DHZC-2 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.

Consumer 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.htm

• 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 Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm516496.htm