Drug & medication recalls Moderate risk

Durisan Antimicrobial Solutions Hand Sanitizing Wipes recalled over manufacturing violations

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%, packaged in 80-count canister (UP…
Recall number
D-0659-2021
FDA classification
Class II
Brand / firm
Sanit Technologies, LLC dba Durisan
Sold / distributed
Nationwide in the USA and Bahamas

Why it was recalled

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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