Drug & medication recalls High risk

Durisan Antimicrobial Solutions Hand Sanitizing Wipes recalled over sterility concerns

Recall date
March 10, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Sanit Technologies, LLC dba Durisan recalls Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technol…
Recall number
D-0657-2021
FDA classification
Class I
Brand / firm
Sanit Technologies, LLC dba Durisan
Sold / distributed
Nationwide in the USA and Bahamas

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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