Felt, OK, McDaniel Life-Line LLC is recalling all lots of Indian Herb b because it is marketed without an approved NDA/ANDA (new drug application/abbreviated new drug application). The recall statement says, “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.”
An NDA helps the FDA decide “whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.” NDAs have been in place since 1938. Every new drug is the subject of an NDA before it can be sold as a commercial product.
This product is taken internally or applied externally to abnormal skin growths. The product is packaged in 6 dram vials. The recall affects all lots of Indian Herb. It was sold in the United States, Italy, Canada, Australia, and Poland over the internet.
If you purchased this product, stop using it immediately. You can throw it away in a sealed package, or return it for a refund.
If you have had an adverse reaction to this product, you can find a report with the FDA through its MedWatch Adverse Event Reporting Program.
