Home / Recalls / Sanit Technologies, LLC dba Durisan / D-0659-2021

D-0659-2021 Class II Terminated

Recalled by Sanit Technologies, LLC dba Durisan — Sarasota, FL

FDA drug recall D-0659-2021 was initiated by Sanit Technologies, LLC dba Durisan on March 10, 2021 and is designated Class II. 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. The recall status is terminated (terminated January 19, 2022). Affected quantity: 43,164 canisters TOTAL.

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