D-1355-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 24, 2022
- Initiation Date
- July 15, 2022
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
Product Description
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 for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Distribution Pattern
Florida, Illinois, Iowa, New Jersey
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