- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionUnapproved drug. Marketed without an approved NDA/ANDA
- Company Name:
- McDaniel Life-Line LLC
- Brand Name:
Brand Name(s)McDaniel Life-Line
- Product Description:
Product DescriptionIndian Herb (topical)
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@example.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 firstname.lastname@example.org, 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- McDaniel Life-Line