Drugs

FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb

[2/12/19] FDA is alerting patients of a voluntary recall of all lots of unapproved Indian Herb made and distributed by McDaniel Life-Line, Felt, Oklahoma, because it was manufactured under poor conditions. The agency has concerns this product’s ingredients may burn through the skin, causing serious patient injury.

FDA recommends patients who have Indian Herb stop using it immediately and discard it. Using the product could result in a disfiguring chemical amputation, which could require plastic surgery. FDA also recommends patients not use McDaniel’s Life-Line Water, due to the potential for hazardous microbial contamination.

To date, McDaniel Life-Line has received one report of an injury related to its Indian Herb product. McDaniel distributed this product to individuals in the United States, Italy, Canada, Australia and Poland through the company’s website, www.lifelinewater.com.

Patients who have questions regarding this recall can contact McDaniel Life-Line by phone 806-647-1471 or by email, lifeline@amaonline.com, Monday through Friday, from 8 a.m. to 5 p.m. Central Time. Patients should contact their physician or health care professional if they have experienced any problems that may be related to using these products.

Patients and health care professionals should report any adverse reactions related to the use of McDaniel Life-Line products to FDA’s MedWatch program:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.

 

Page Last Updated: 02/12/2019
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