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# Warning Sent to Maison Terre After Infant Death
- URL: https://www.fdaweb.com/warning-sent-to-maison-terre-after-infant-death/
- Published: 2021-04-13T12:00:00.000Z
- Updated: 2026-09-14T16:54:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149102

FDA 4/1 issued a [Warning Letter ](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maison-terre-llc-610315-04012021?ref=fdaweb.com)to Maison Terre after conducting testing on its drug product labeled as “Goldenseal Root Powder Organic” and determining the repackaged product was prepared, packed, or held under insanitary conditions. The letter said the agency was aware of a report of one infant death associated with the drug product’s use on the umbilical cord stump.The agency also said the product was considered an unapproved new drug.

FDA said that its testing found the product to be contaminated and contained more than 260,000 cfu/g of total aerobic microbial growth and more than 5,000 cfu/g of total yeast and mold growth. “Moreover, FDA laboratory testing also found that your ‘Goldenseal Root Powder Organic’ drug product contained the presence of several objectionable microorganisms, including but not limited to: *Enterobacter cloacae, Klebsiella pneumoniae,* and *Cronobacter sakazakii*. These are significant opportunistic pathogens that can cause serious infections and diseases.”