United States
Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer and hand sanitizing wipes
Reason of the recall: Microbial contamination
FDA Recall date: June 22, 2021
Recall details: 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: 18. Volume oz: 0.61. UPC: 8 52379 00614 1. NDC: 71120-112-01.
- Volume mL: 50. Volume oz: 1.69. UPC: 8 52379 00634 9. NDC: 71120-611-20.
- Volume mL: 118. Volume oz: 4. UPC: 8 52379 00612 9. NDC: 71120-112-10.
- Volume mL: 236. Volume oz: 8. UPC: 8 52379 00635 6. NDC: 71120-112-11.
- Volume mL: 250. Volume oz: 8.45. UPC: 8 52379 00611 0. NDC: 71120-611-03.
- Volume mL: 300. Volume oz: 10. UPC: 8 52379 00697 4. NDC: 71120-112-08.
- Volume mL: 550. Volume oz: 18.59. UPC: 8 52379 00620 2. NDC: 71120-112-06.
- Volume mL: 1000. Volume oz: 33.81. UPC: 8 52379 00610 3. NDC: 71120-112-05.
- Volume mL: 3785. Volume oz: 128. UPC: 8 52379 00621 9. NDC: 71120-611-05.
- Volume mL: 160 Ct Wipe. Volume oz: 5.63. UPC: 8 52379 00631 8. NDC: 71120-111-01.
- Volume mL: 80 Ct Wipe. Volume oz: 2.81. UPC: 8 52379 00632 5. NDC: 71120-111-03.
- Volume mL: 240 Ct Wipe. Volume oz: 8.44. UPC: 8 52379 00633 2. NDC: 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.
Check the full recall details on
www.fda.gov
Source: FDA
