08.24.20
According to the FDA, a microbial outbreak in a topical goldenseal product was linked to the death of an infant, leading the company to voluntarily recall all of the Goldenseal Root Powder products it sold over a period spanning over five years. The adverse event raised the alarm on the potential for microbial issues in goldenseal, and more generally, botanical products.
The FDA recently announced that Maison Terre, a company which sells Goldenseal Root Powder, is voluntarily recalling this product, which was purchased from Starwest Botanicals and repackaged for retail sale due to a microbial contamination, which resulted in the death of an infant who sustained an infection.
FDA’s analysis found that the goldenseal products it sampled were contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, and others. Cronobacter species have been linked to the majority of neonatal meningitis cases over the past 30 years, and Cronobacter outbreaks have happened in several products including infant formula, cotton, and other consumer packaged goods.
FDA warns that the use of contaminated product in otherwise healthy patients can result in infections necessitating antimicrobial and potentially surgical treatment. The product can be deadly for infants or people with weakened immune systems, FDA reports. Maison Terre received a report of one infant death associated with the topical use of this product on the umbilical cord stump.
The Goldenseal Root Powder is yellow-colored, and comes in a clear plastic bag, with a net weight of 1 oz., and consumers are being urged to dispose of any unused product.
The recalled Goldenseal Root Powder was distributed nationwide in the USA to customers who ordered through Amazon.com, purchased between Jan. 25, 2015 and Aug. 4, 2020. Maison Terre is notifying its customers by email through Amazon.com, and information regarding the recall, questions about returns or refunds, and other information is available by contacting Maison Terre at 501-888-9438 Mon-Fri, 10 a.m. to 4 p.m. CST or at info@maisonterre.net.
American Herbal Pharmacopoeia, a nonprofit educational organization specializing in herbal medicines, sent out a notice to its members and associates regarding the incident. Roy Upton, RH, DipAyu, president of AHP, recommended that all goldenseal companies test their products for the specific microbes.
“This is a potential game changer for goldenseal and microbial issues for botanicals in general,” Upton wrote. “We recommend that you test your goldenseal for the specific microbes listed whether you obtained it from the supplier or not. Though several microbial strains were detected, most likely, the causative factor was Cronobacter sakazakii, as that is well known to result in infantile infections. Where the bacteria originated is not known. It has been reported in infant formulas as well as in 12-13% of vegetables, and even tampons, and can persist in dry material for up to two years, so material that was tested and accepted at time of receipt may develop it over time.”
The FDA recently announced that Maison Terre, a company which sells Goldenseal Root Powder, is voluntarily recalling this product, which was purchased from Starwest Botanicals and repackaged for retail sale due to a microbial contamination, which resulted in the death of an infant who sustained an infection.
FDA’s analysis found that the goldenseal products it sampled were contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, and others. Cronobacter species have been linked to the majority of neonatal meningitis cases over the past 30 years, and Cronobacter outbreaks have happened in several products including infant formula, cotton, and other consumer packaged goods.
FDA warns that the use of contaminated product in otherwise healthy patients can result in infections necessitating antimicrobial and potentially surgical treatment. The product can be deadly for infants or people with weakened immune systems, FDA reports. Maison Terre received a report of one infant death associated with the topical use of this product on the umbilical cord stump.
The Goldenseal Root Powder is yellow-colored, and comes in a clear plastic bag, with a net weight of 1 oz., and consumers are being urged to dispose of any unused product.
The recalled Goldenseal Root Powder was distributed nationwide in the USA to customers who ordered through Amazon.com, purchased between Jan. 25, 2015 and Aug. 4, 2020. Maison Terre is notifying its customers by email through Amazon.com, and information regarding the recall, questions about returns or refunds, and other information is available by contacting Maison Terre at 501-888-9438 Mon-Fri, 10 a.m. to 4 p.m. CST or at info@maisonterre.net.
American Herbal Pharmacopoeia, a nonprofit educational organization specializing in herbal medicines, sent out a notice to its members and associates regarding the incident. Roy Upton, RH, DipAyu, president of AHP, recommended that all goldenseal companies test their products for the specific microbes.
“This is a potential game changer for goldenseal and microbial issues for botanicals in general,” Upton wrote. “We recommend that you test your goldenseal for the specific microbes listed whether you obtained it from the supplier or not. Though several microbial strains were detected, most likely, the causative factor was Cronobacter sakazakii, as that is well known to result in infantile infections. Where the bacteria originated is not known. It has been reported in infant formulas as well as in 12-13% of vegetables, and even tampons, and can persist in dry material for up to two years, so material that was tested and accepted at time of receipt may develop it over time.”
