Drug product
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
D-1356-2022
Product summary
- Event
- Event 90644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,176 cartons
- Official record key
drug-enforcement:D-1356-2022
Official wording
Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Code information: Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22
Distribution pattern: Florida, Illinois, Iowa, New Jersey
Derived failure modes
-
Manufacturing or process control
CGMP Deviations