Sanit Technologies, LLC dba Durisan: Drug Recall

Recall #D-0657-2021 · 03/10/2021

Class I: Dangerous

Recall Details

Recall Number: D-0657-2021
Classification: Class I
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: 42,905 canisters TOTAL

Reason for Recall

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.

Product Description

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.

Distribution Pattern

Nationwide in the USA and Bahamas

Other Recalls by Sanit Technologies, LLC dba Durisan

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 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.