Drug product
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
D-0220-2021
Product summary
- Event
- Event 86709
- Status
- Terminated
- Classification
- Class I
- Quantity
- 298 jars
- Official record key
drug-enforcement:D-0220-2021
Official wording
Reason: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Code information: P116 - Exp. 12/2020; P117 - Exp. 05/2021; P118 - Exp. 10/2021; P119 - Exp. 01/2022; P120 - Exp. 04/2022
Distribution pattern: Distributed Nationwide in the USA, Egypt and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination