Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lots: DHS030920A1-A, DHS030920A2-S, DHS030920A3-S, Exp. 4/9/2022; DHS031020A4-S, DHS031020A5-S, DHS031020A6-S, DHS031020A7-S, DHS031020A8-S, Exp. 4/10/2022; DHS031120A1-S, DHS031120A2-S, DHS031120A3-S, DHS031120A4-S, DHS031120A5-S, DHS031120A6-S, Exp.4/11/2022; DHS051420A1-S, Exp. 6/14/2022; DHS052020A1-S, DHS052020B1-S, DHS052020C1-S, Exp. 6/20/2022; DHS052220B1-S, Exp. 6/22/2022; DHS052620B1-S, Exp. 6/26/2022; DHS052720C1-S, DHS052720D1-S, Exp. 6/27/2022, DHS052820B1-S, DHS052820C1-S, DHS052820D1-S, Exp. 6/28/2022; DHS060120A1-S, Exp. 7/1/2022; DHS060220A1-S, DHS062220C-S, Exp. 7/22/2022
Where it was sold
Nationwide in the USA and Bahamas
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0656-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 10, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanit Technologies, LLC dba Durisan
Original FDA data
Every field from FDA enforcement report D-0656-2021, exactly as published.
Show all FDA fields
- City
- Sarasota
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87511
- Address
- 7810 25th Ct E Unit 106
- Code information
- Lots: DHS030920A1-A, DHS030920A2-S, DHS030920A3-S, Exp. 4/9/2022; DHS031020A4-S, DHS031020A5-S, DHS031020A6-S, DHS031020A7-S, DHS031020A8-S, Exp. 4/10/2022; DHS031120A1-S, DHS031120A2-S, DHS031120A3-S, DHS031120A4-S, DHS031120A5-S, DHS031120A6-S, Exp.4/11/2022; DHS051420A1-S, Exp. 6/14/2022; DHS052020A1-S, DHS052020B1-S, DHS052020C1-S, Exp. 6/20/2022; DHS052220B1-S, Exp. 6/22/2022; DHS052620B1-S, Exp. 6/26/2022; DHS052720C1-S, DHS052720D1-S, Exp. 6/27/2022, DHS052820B1-S, DHS052820C1-S, DHS052820D1-S, Exp. 6/28/2022; DHS060120A1-S, Exp. 7/1/2022; DHS060220A1-S, DHS062220C-S, Exp. 7/22/2022
- Postal code
- 34243-2841
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0656-2021
- Classification
- Class I
- Recalling firm
- Sanit Technologies, LLC dba Durisan
- Product quantity
- 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL
- Termination date
- Jan 19, 2022
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Mar 10, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2021