Monday, March 30, 2020

Monday, March 30, 2020

U.S. FOOD AND DRUG ADMINISTRATION: Life Rising Corporation Recalls Chinese Herbal Supplements Because of Possible Health Risk


U.S. Food and Drug Administration recently issued the following announcement. 

Summary

Company Announcement Date: May 02, 2019

FDA Publish Date: May 03, 2019

Product Type: Dietary Supplements

Reason for Announcement: Food & Beverage Safety, Potential Metal or Chemical Contaminant, Lead

Company Name: Life Rising Corporation

Brand Name: Life Rising, HoliCare

Product Description: Dietary supplements

Company Announcement

Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead. According to FDA instruction, lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. 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.

The recalled products were mostly sold locally in Chicago area at HoliCare clinics and a limited quantity were also distributed through mail orders.

The recall includes all products purchased before May 2, 2019 of the Life Rising Holder-W Holder Warmer capsules and Life Rising NECK-ND Neck Clear capsules and lot number T81171040 of the HoliCare Metabolism Cleansing (MET-CLS) tablets. The Life Rising Holder-W Holder Warmer capsules are sold in a bottle with 54 capsules, the Life Rising NECK-ND Neck Clear capsules are sold in a bottle with 54 capsules, and the HoliCare Metabolism Cleansing (MET-CLS) tablets are sold in a bottle with 60 tablets, marked with lot # T81171040 on the bottom.

No illnesses have been reported to date.

The recall was initiated after it was discovered based on sampling by U.S. Food and Drug Administration that the products contained high levels of lead which exceeded the new daily limit guidelines of 3 µg per day for children, the 12.5 µg per day for adults which we were informed by FDA on May 1, 2019.

The sale of these products has been suspended and inventory put on hold while FDA and the company continue to investigate the source of the problem. Consumers who have purchased these products should not consume them and are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-630-654-0617 central standard time, Monday to Friday, from 9:00AM to 4:30PM.

Original source can be found here.

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U.S. Food and Drug Administration (FDA)

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