SARASOTA, Fla., June 20, 2021 /PRNewswire/ -- Sanit
Technologies LLC d/b/a Durisan, is providing an additional 5 label
illustrations and product sizes for customers that might not have
been able to clearly identify containers of Non-Alcohol Hand
Sanitizer products that were added to the voluntary recall
initiated on March 24, 2021, and
expanded by the April 10 and
May 14, 2021 notices. To avoid any
confusion, this press release provides copies of label
illustrations for the recalled products.
Durisan Non Alcohol Antimicrobial Hand Sanitizer products became
contaminated with a common municipal water supply borne bacteria,
Burkholderia contaminans. Use of a hand sanitizer contaminated with
Burkholderia contaminans, generally considered to be of low
virulence, can range from no reaction to possible infections in a
person with a hand wound or scrapes because the bacteria could
enter the bloodstream, especially in patients with compromised
immune systems.
To date, no qualified reports of adverse reactions have been
reported related to this recall.
The product is intended to be applied topically to help reduce
bacteria on the skin that could cause diseases when soap and water
are not available.
The list of the lot numbers of the recalled products, which have
a 24-month expiration, is included below. Consumers and customers
in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer
products with these numbers in any form factor are encouraged to
contact Durisan to return it.
The product is packaged in sizes ranging from 18mL credit card
to 1-gallon containers. The lot number can be found in black print
on the bottom of the package.
Durisan
Antimicrobial Solutions Hand Sanitizer Sizes With the Following
Identification
|
|
|
|
|
Volume mL
|
Volume oz
|
UPC
|
NDC
|
18
|
0.61
|
8 52379 00614
1
|
71120-112-01
|
50
|
1.69
|
8 52379 00634
9
|
71120-611-20
|
118
|
4
|
8 52379 00612
9
|
71120-112-10
|
236
|
8
|
8 52379 00635
6
|
71120-112-11
|
250
|
8.45
|
8 52379 00611
0
|
71120-611-03
|
300
|
10
|
8 52379 00697
4
|
71120-112-08
|
550
|
18.59
|
8 52379 00620
2
|
71120-112-06
|
1000
|
33.81
|
8 52379 00610
3
|
71120-112-05
|
3785
|
128
|
8 52379 00621
9
|
71120-611-05
|
160 Ct
Wipe
|
5.63
|
8 52379 00631
8
|
71120-111-01
|
80 Ct Wipe
|
2.81
|
8 52379 00632
5
|
71120-111-03
|
240 Ct
Wipe
|
8.44
|
8 52379 00633
2
|
71120-111-03
|
Durisan has provided written notification to its distributors
and retailers and is alerting customers via this voluntary recall.
Consumers that have the product are advised to contact Durisan to
return it.
Consumers with questions regarding this recall can contact
Durisan at 941-351-9114, 8:30 am - 4:30 pm
Eastern time, Monday through Friday or by email at
customerservice@durisan.com.
Consumers should contact their physician or healthcare provider
if they have experienced any problems that may be related to using
this drug product.
Adverse reactions or quality problems experienced with the use
of this product may be reported to the FDA's MedWatch Adverse Event
Reporting program either online by regular mail or by fax.
- Complete and submit the report Online External Link
Disclaimer
- Regular Mail or Fax: Download form External Link Disclaimer or
call 1- 800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
Company Contact Information
Consumers:
Durisan
941-351-9114
customerservice@durisan.com
Lot
Number
|
DHS051420A1-S
|
DHS041519A1-S
|
DHS051520A1R1-S
|
DHS041519A2-S
|
DHS052020A1-S
|
DHS041519A3-S
|
DHS052020A1R1-S
|
DHS041519A4-S
|
DHS052020B1-S
|
DHS041519A5-S
|
DHS052020B1R1-S
|
DHS041519A6-S
|
DHS052020C1-S
|
DHS042919AR1-S
|
DHS052020CR1-S
|
DHS043019AR1-S
|
DHS052220A1R1-S
|
DHS050319A4-S
|
DHS052220B1-S
|
DHS053019A1-S
|
DHS052620B1-S
|
DHS053019A2-S
|
DHS052720C1-S
|
DHS053019A4-S
|
DHS052720C1R1-S
|
DHS053019A5-S
|
DHS052720D1-S
|
DHS053019A6-S
|
DHS052820B1-S
|
DHS070219A1-S
|
DHS052820C1-S
|
DHS070219A2-S
|
DHS052820D1-S
|
DHS070219A3-S
|
DHS052920A1R1-S
|
DHS070219A4-S
|
DHS052920B1R1-S
|
DHS070219A5-S
|
DHS052920C1R1-S
|
DHS070219A6-S
|
DHS060120A1-S
|
DHS070219AB-S
|
DHS060220A1-S
|
DHS080219A1-S
|
DHS060320C1R1-S
|
DHS091819A1-S
|
DHS060520C1R1-S
|
DHS030920A1-S
|
DHS060520F1R1-S
|
DHS030920A2-S
|
DHS060820E1R1-S
|
DHS030920A3-S
|
DHS061220A1R1-S
|
DHS031020A4-S
|
DHS061920B1R1-S
|
DHS031020A5-S
|
DHS062220C-S
|
DHS031020A6-S
|
DHS062320B1R1-S
|
DHS031020A7-S
|
DHS062420B1R1-S
|
DHS031020A8-S
|
DHS081120A1-S
|
DHS031120A1-S
|
DHS081220A1R1-S
|
DHS031120A2-S
|
DHS081420B1-S
|
DHS031120A3-S
|
DHS081420B3-S
|
DHS031120A4-S
|
DHS081420B6-S
|
DHS031120A5-S
|
DHS081420B8-S
|
DHS031120A6-S
|
DHS081720A3-S
|
DHS032820B1-S
|
DHS081720A5-S
|
Related Files
final labels.pdf
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content:http://www.prnewswire.com/news-releases/sanit-technologies-adds-label-clarification-to-existing-voluntary-hand-sanitizer-recall-301315993.html
SOURCE Sanit Technologies