FDA recall D-0659-2021

Sanit Technologies, LLC dba Durisan · Class II · drug

Product

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

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-0659-2021