Class II Recall

Aire-Master of America Inc

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
Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Classification
Class II
Status
Terminated
Lot
[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
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.