Drug product
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
D-1360-2022
Product summary
- Event
- Event 90644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 totes
- Official record key
drug-enforcement:D-1360-2022
Official wording
Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Code information: Product Number 46137, Lot 724640-exp 11/22, 729955-exp 01/24
Distribution pattern: Florida, Illinois, Iowa, New Jersey
Derived failure modes
-
Manufacturing or process control
CGMP Deviations