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 Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.
Lot numbers, UPCs & expiration codes
Lots: DHS031020A4-S, DHS031020A6-S, Exp. 4/10/2022
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-0657-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 10, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 42,905 canisters TOTAL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanit Technologies, LLC dba Durisan
Original FDA data
Every field from FDA enforcement report D-0657-2021, 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: DHS031020A4-S, DHS031020A6-S, Exp. 4/10/2022
- Postal code
- 34243-2841
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0657-2021
- Classification
- Class I
- Recalling firm
- Sanit Technologies, LLC dba Durisan
- Product quantity
- 42,905 canisters 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 Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.
- Distribution pattern
- Nationwide in the USA and Bahamas
- Recall initiation date
- Mar 10, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2021