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 [email protected].
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 [email protected], 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.