Felt, Oklahoma-based McDaniel Life-Line, LLC is voluntarily recalling all lots of Indian Herb because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish it as intended to affect the structure, or any function of the body. Additionally, the product contains ingredients that the FDA has determined to be caustic in nature, which 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.
It was distributed in the United States, Italy, Canada, Australia and Poland. Consumers that have product which is being recalled should stop using and discard.
