August 2020 FDA Recall Drug by Maison Terre, Llc
D-1584-2020 - Microbial Contamination of Non-Sterile Products
This Class I drug recall was voluntarily initiated by Maison Terre, Llc on August 17, 2020 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1584-2020
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
08-17-2020
09-23-2020
670 bags
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Maison Terre, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
01-27-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
Batch or Lot Expiration Information
Lot# All lots distributed 01/25/2015 to 08/04/2020
