Sanit Technologies, LLC dba Durisan: Drug Recall

Recall #D-0658-2021 · 03/10/2021

Class II: Risk

Recall Details

Recall Number
D-0658-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Sanit Technologies, LLC dba Durisan
Status
Terminated
Date Initiated
03/10/2021
Location
Sarasota, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL

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.

Product Description

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243

Distribution Pattern

Nationwide in the USA and Bahamas

Other Recalls by Sanit Technologies, LLC dba Durisan

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.