The U.S. Food and Drug Administration announced that Sanit Technologies had expanded the recall on its Durisan non-alcohol hand sanitizer because it's contaminated with Burkholderia contaminants.
According to the FDA, the bacteria can get into the bloodstream if they use hand sanitizer while they have a wound on their hand.
"Use of a hand sanitizer contaminated with Burkholderia contaminants, 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," the FDA said in the recall notice.
The initial recall was issued in March. Then expanded in April.
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FDA said the recall was expanded due to the company discovering "that promotional orders, as well as small run production lot numbers which were not listed, were intended for inclusion in the recall."
The FDA said consumers had not reported any qualified reports of adverse reactions related to this recall.
The Durisan products that are being recalled:
.61 ounces, UPC No. 8 52379 00614 1, NDC No. 71120-112-01
4 ounces, UPC No. 8 52379 00634 9, NDC No. 71120-112-10
8 ounces, UPC No. 8 52379 00635 6, NDC No. 71120-112-11
10 ounces, UPC No. 8 52379 00697 4, NDC No. 71120-112-08
18.59 ounces, UPC No. 8 52379 00620 2, NDC No. 71120-112-06
33.81 ounces, UPC No. 8 52379 00610 3, NDC No. 71120-112-05
160 (160 Ct Wipe) UPC No. 8 52379 00631 8, NDC No. 71120-111-01
80 (80 Ct Wipe), UPC No. 8 52379 00632 5, NDC No. 71120-111-02
240 (240 Ct Wipe), UPC No. 8 52379 00633 2, NDC No. 71120-111-03
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 Regular Mail or Fax: Download form 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
If you have any questions, consumers can contact Durisan at 941-351-9114, 8:30 a.m. to 4:30 p.m. ET during the week, or send an email to customerservice@durisan.com.
