U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb

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.

Read Announcement View Product Photos

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Prescription Drugs
Reason for Announcement:
Recall Reason Description
Unapproved drug. Marketed without an approved NDA/ANDA
Company Name:
McDaniel Life-Line LLC
Brand Name:
Brand Name(s)
McDaniel Life-Line
Product Description:
Product Description
Indian Herb (topical)

Company Announcement

Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body.  Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

Use of the product could result in temporary or permanent damage or loss of body function or structure.  To date, McDaniel Life-Line LLC has received a report of one adverse injury.

The product can be taken internally or applied externally to abnormal skin growths. The product is  packaged in 6 dram vials. The affected Indian Herb includes all lots.  Product was distributed in the United States, Italy, Canada, Australia and Poland to individuals via internet sales@lifelinewater.com.

McDaniel Life-Line LLC is notifying its customers by press release of the recalled product. Consumers that have product which is being recalled should stop using and discard.

Consumers with questions regarding this recall can contact McDaniel Life-Line by phone 806-647-1471 or by e-mail lifeline@amaonline.com, Monday thru Friday 8 AM-5 PM, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
McDaniel Life-Line
806-647-1471
lifeline@amaonline.com

Product Photos