Drug product
Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
D-1584-2020
Product summary
- Event
- Event 86268
- Status
- Terminated
- Classification
- Class I
- Quantity
- 670 bags
- Official record key
drug-enforcement:D-1584-2020
Official wording
Reason: 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.
Code information: All lots distributed 01/25/2015 to 08/04/2020
Distribution pattern: Nationwide.
Derived failure modes
-
Microbial contamination
Microbial Contamination