McDaniel Life-Line is recalling all lots of Indian Herb to the consumer level.
The product is marketed without an approved New Drug Application/Abbreviated New Drug Application (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, it contains ingredients that have been 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.
McDaniel Life-Line has received one report of an adverse effect to date.
The product, which can be taken internally or applied externally to abnormal skin growths, is packaged in 6-dram vials.
It was distributed online to consumers in the U.S., Italy, Canada, Australia and Poland.
What to do
Customers who purchased the recalled product should stop using and discard it.
Consumers with questions may contact McDaniel Life-Line at (806) 647-1471 Monday through Friday, 8 AM – 5 PM (CT) or by e-mail at email@example.com.