The Recall Desk

FDA (Drugs) recall action 87511

Sanit Technologies, LLC dba Durisan recalled 4 products on 2021-07-21

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-07-21
Critical
0
Units
86,069

Why these products were recalled

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

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Drugs)··2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations

    Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.

    Product
    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,
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for Microbial Contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes because certain lots were found to contain Burkholderia contaminans and/or yeast and mold through internal testing.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-07-21

    Durisan Antimicrobial Hand Sanitizer Recalled for Manufacturing Deviations

    Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.

    Product
    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 0061
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-07-21

    Durisan Antimicrobial Hand Sanitizer recalled for microbial contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions hand sanitizer due to internal testing that found contamination with Burkholderia contaminans and/or yeast and mold in certain lots.

    Product
    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 0061
    Category
    Distribution
    0 states