FDA recall D-0657-2021

Sanit Technologies, LLC dba Durisan · Class I · drug

Product

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.

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

Key facts

Status
Terminated
Initiation date
2021-03-10
Report date
2021-07-21
Termination date
2022-01-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0657-2021