Drug product
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
D-1355-2022
Product summary
- Event
- Event 90644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
- Official record key
drug-enforcement:D-1355-2022
Official wording
Reason: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Code information: [Product number], lot code, expiry: a) [46016] Lot 722770, exp 07/22 b) [46017] Lot 722995-exp 07/22, 727370-exp 07/23, 727898-exp 09/23, 728005-exp 08/23, 729522-exp12/23, 730412-exp 03/24, 730861-exp 04/24 c) [46138] Lot 725188-exp 12/22
Distribution pattern: Florida, Illinois, Iowa, New Jersey
Derived failure modes
-
Manufacturing or process control
CGMP Deviations