FDA Recall D-0657-2021
Sanit Technologies, LLC dba Durisan · Sarasota, FL
Class I — life-threatening Terminated 315 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0657-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and Bahamas
- Recall initiated
- 2021-03-10
- Classified by FDA Center
- 2021-07-13
- FDA published
- 2021-07-21
- Terminated
- 2022-01-19
- Recalling firm
- Sanit Technologies, LLC dba Durisan
- Firm location
- Sarasota, FL