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.
D-0657-2021
Product summary
- Event
- Event 87511
- Status
- Terminated
- Classification
- Class I
- Quantity
- 42,905 canisters TOTAL
- Official record key
drug-enforcement:D-0657-2021
Official wording
Reason: 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.
Code information: Lots: DHS031020A4-S, DHS031020A6-S, Exp. 4/10/2022
Distribution pattern: Nationwide in the USA and Bahamas
Derived failure modes
-
Microbial contamination
Microbial Contamination