Summary Company Announcement Date: August 17, 2020 FDA Publish Date: August 18, 2020 Product Type: Drugs Reason for Announcement:

Recall Reason Description

Due to microbial contamination

North Little Rock, AR, Maison Terre is voluntarily recalling all lots of its Goldenseal Root Powder, purchased from Starwest Botanicals, Sacramento, CA, and repackaged to the consumer level due to microbial contamination. FDA laboratory analysis of product samples found these products to be contaminated with various microorganisms including: Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.

Risk Statement: The use of contaminated product in otherwise healthy patients can result in infections necessitating antimicrobial and potentially surgical treatment. In individuals with weak immune systems and infants, the use of the product can result in death. Maison Terre has received a report of one infant death associated with use of this product on the umbilical cord stump.

The product is a yellow colored powder that comes in a clear plastic bag, net weight of 1 oz.

The recalled Goldenseal Root Powder was distributed nationwide in the USA to customers who ordered through Amazon.com and purchased between the dates of 01/25/2015 to 08/04/2020.

Maison Terre is notifying its customers by email through Amazon.com. Customers who have purchased the Goldenseal Root Powder are urged not to consume or apply it. Customers are urged to dispose of any unused portion. For those customers wanting to return the product for a refund, please contact Maison Terre for a return shipping label.

Customers with questions regarding this recall may contact Maison Terre at 501-888-9438, Mon-Fri, 10 am - 4 pm CST or at info@maisonterre.net. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.

Maison Terre is conducting this recall with the knowledge of the U.S. Food and Drug Administration.

Read more:

Maison Terre Issues Voluntary Nationwide Recall of Organic Goldenseal Root Powder Due to Microbial Contamination - FDA.gov