Drug product
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
D-1359-2022
Product summary
- Event
- Event 90644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,064 bottles
- Official record key
drug-enforcement:D-1359-2022
Official wording
Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Code information: Product Number 46111, Lot 722781-exp 09/22
Distribution pattern: Florida, Illinois, Iowa, New Jersey
Derived failure modes
-
Manufacturing or process control
CGMP Deviations