Sanit Technologies, LLC dba Durisan: Drug Recall

Recall #D-0659-2021 · 03/10/2021

Class II: Risk

Recall Details

Recall Number: D-0659-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Sanit Technologies, LLC dba Durisan
Status: Terminated
Date Initiated: 03/10/2021
Location: Sarasota, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 43,164 canisters TOTAL

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.

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.

Distribution Pattern

Nationwide in the USA and Bahamas

Other Recalls by Sanit Technologies, LLC dba Durisan

Class I: Dangerous 03/10/2021

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Class II: Risk 03/10/2021

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class I: Dangerous 03/10/2021

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

View all recalls by Sanit Technologies, LLC dba Durisan →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.