Why it was recalled
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Product description
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243.
Lot numbers, UPCs & expiration codes
DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, Exp. 5/15/2021; DHS042919AR1-S, Exp. 5/29/2021; DHS043019AR1-S, Exp. 5/30/2021; DHS050319A4-S, Exp. 6/03/2021; DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, Exp. 6/30/2021; DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, Exp. 8/2/2021; DHS080219A1-S, Exp. 9/2/2021; DHS091819A1-S, Exp 10/18/2021; DHS032820B1-S, Exp 4/28/2022; DHS051520A1R1-S, Exp. 6/15/2022; DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, Exp. 6/20/2022; DHS052220A1R1-S, Exp. 6/22/2022; DHS052720C1R1-S, Exp 6/27/2022; DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, Exp 6/29/2022; DHS060320C1R1-S, Exp. 7/3/2022; DHS060520C1R1-S, DHS060520F1R1-S, Exp. 7/5/2022; DHS060820E1R1-S, Exp. 7/8/2022; DHS061220A1R1-S, Exp. 7/12/2022; DHS061920B1R1-S, Exp. 7/19/2022; DHS062320B1R1-S, Exp. 7/23/2022; DHS062420B1R1-S, Exp. 7/24/2022; DHS081120A1-S, Exp. 9/11/2022; DHS081220A1R1-S, Exp 9/12/2022; DHS081420B1-S, DHS081420B3-S, DHS081420B6-S, DHS081420B8-S, Exp. 9/14/2022; DHS081720A3-S, DHS081720A5-S, Exp. 9/17/2022
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-0659-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 43,164 canisters TOTAL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sanit Technologies, LLC dba Durisan
Original FDA data
Every field from FDA enforcement report D-0659-2021, 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
- DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, Exp. 5/15/2021; DHS042919AR1-S, Exp. 5/29/2021; DHS043019AR1-S, Exp. 5/30/2021; DHS050319A4-S, Exp. 6/03/2021; DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, Exp. 6/30/2021; DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, Exp. 8/2/2021; DHS080219A1-S, Exp. 9/2/2021; DHS091819A1-S, Exp 10/18/2021; DHS032820B1-S, Exp 4/28/2022; DHS051520A1R1-S, Exp. 6/15/2022; DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, Exp. 6/20/2022; DHS052220A1R1-S, Exp. 6/22/2022; DHS052720C1R1-S, Exp 6/27/2022; DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, Exp 6/29/2022; DHS060320C1R1-S, Exp. 7/3/2022; DHS060520C1R1-S, DHS060520F1R1-S, Exp. 7/5/2022; DHS060820E1R1-S, Exp. 7/8/2022; DHS061220A1R1-S, Exp. 7/12/2022; DHS061920B1R1-S, Exp. 7/19/2022; DHS062320B1R1-S, Exp. 7/23/2022; DHS062420B1R1-S, Exp. 7/24/2022; DHS081120A1-S, Exp. 9/11/2022; DHS081220A1R1-S, Exp 9/12/2022; DHS081420B1-S, DHS081420B3-S, DHS081420B6-S, DHS081420B8-S, Exp. 9/14/2022; DHS081720A3-S, DHS081720A5-S, Exp. 9/17/2022
- Postal code
- 34243-2841
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0659-2021
- Classification
- Class II
- Recalling firm
- Sanit Technologies, LLC dba Durisan
- Product quantity
- 43,164 canisters TOTAL
- Termination date
- Jan 19, 2022
- Reason for recall
- CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, 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