Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
FDA recall notice · announced August 24, 2022 · Aire-master
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Reason for recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Notes
Distribution: Florida, Illinois, Iowa, New Jersey
Lot/code information: Product Number 46137, Lot 724640-exp 11/22, 729955-exp 01/24
Quantity: 4 totes
Status: Terminated
Products in this recall event:
- Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606. (D-1358-2022)
- Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606 (D-1359-2022)
- 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)
- 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)
- 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)
- Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734 (D-1360-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.