Drug product
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
D-0219-2021
Product summary
- Event
- Event 86709
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1651 jars
- Official record key
drug-enforcement:D-0219-2021
Official wording
Reason: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Code information: Lot #: P227 - Exp. 11/2020; P228 - Exp. 12/2020; P229 - Exp. 02/2021; P230 - Exp. 04/2021; P231 - Exp. 06/2021; P232 - Exp. 09/2021; P233 - Exp. 01/2022; P234 - Exp. 05/2022; P235 - Exp. 08/2022
Distribution pattern: Distributed Nationwide in the USA, Egypt and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination