FDA advises consumers and health care professionals not to use goldenseal root powder repackaged and distributed by Maison Terre, Little Rock, Arkansas, due to microbial contamination.
FDA laboratory analysis found the product is contaminated with high counts of various bacteria, including multiple pathogens. Use of these contaminated products can cause serious infections with severe outcomes, including death, especially in vulnerable patients with compromised immune systems and infants. FDA is aware of one infant death associated with use of this product on the umbilical cord stump.
On August 5 and August 14, 2020, FDA recommended that Maison Terre recall their goldenseal root powder product. To date, the company has not taken action to remove these dangerous products from the market.
Consumers who use goldenseal root powder sold by Maison Terre and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
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