Drug product
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
D-1357-2022
Product summary
- Event
- Event 90644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,632 cartons
- Official record key
drug-enforcement:D-1357-2022
Official wording
Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Code information: Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Distribution pattern: Florida, Illinois, Iowa, New Jersey
Derived failure modes
-
Manufacturing or process control
CGMP Deviations