D-0659-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 21, 2021
- Initiation Date
- March 10, 2021
- Termination Date
- January 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,164 canisters TOTAL
Product Description
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243.
Reason for Recall
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Distribution Pattern
Nationwide in the USA and Bahamas
Code Information
DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, Exp. 5/15/2021; DHS042919AR1-S, Exp. 5/29/2021; DHS043019AR1-S, Exp. 5/30/2021; DHS050319A4-S, Exp. 6/03/2021; DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, Exp. 6/30/2021; DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, Exp. 8/2/2021; DHS080219A1-S, Exp. 9/2/2021; DHS091819A1-S, Exp 10/18/2021; DHS032820B1-S, Exp 4/28/2022; DHS051520A1R1-S, Exp. 6/15/2022; DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, Exp. 6/20/2022; DHS052220A1R1-S, Exp. 6/22/2022; DHS052720C1R1-S, Exp 6/27/2022; DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, Exp 6/29/2022; DHS060320C1R1-S, Exp. 7/3/2022; DHS060520C1R1-S, DHS060520F1R1-S, Exp. 7/5/2022; DHS060820E1R1-S, Exp. 7/8/2022; DHS061220A1R1-S, Exp. 7/12/2022; DHS061920B1R1-S, Exp. 7/19/2022; DHS062320B1R1-S, Exp. 7/23/2022; DHS062420B1R1-S, Exp. 7/24/2022; DHS081120A1-S, Exp. 9/11/2022; DHS081220A1R1-S, Exp 9/12/2022; DHS081420B1-S, DHS081420B3-S, DHS081420B6-S, DHS081420B8-S, Exp. 9/14/2022; DHS081720A3-S, DHS081720A5-S, Exp. 9/17/2022