Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technolo
Summary
The FDA issued a Class I for Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0 by Sanit Technologies, LLC dba Durisan. Reason: Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contam.
Details
Source
Drug Recall
External ID
D-0657-2021
Action Date
2021-07-21
Status
Terminated
Category
drug
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.
Lot/Code Info: Lots: DHS031020A4-S, DHS031020A6-S, Exp. 4/10/2022
Quantity Affected: 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.
Distribution
Nationwide in the USA and Bahamas
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-10
Company
Sarasota, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Sanit Technologies, LLC dba Durisan has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sanit Technologies, LLC dba Durisan) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sanit Technologies, LLC dba Durisan have FDA actions?
Sanit Technologies, LLC dba Durisan has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0657-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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