Durisan Antimicrobial Solutions — Class II drug recall D-0658-2021
Terminated recall by Sanit Technologies, LLC dba Durisan, reported 2021-07-21, distributed nationwide. CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions
| Recall number | D-0658-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanit Technologies, LLC dba Durisan, Sarasota, FL, United States |
| Recall initiated | 2021-03-10 |
| Classified | 2021-07-13 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00850008485077, 00852379006103, 00852379006110, 00852379006127, 00852379006141, 00852379006202, 00852379006219, 00852379006349, 00852379006356, 00852379006974 |
| Lot numbers | DHS032820B1-S, DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, DHS042919AR1-S, DHS043019AR1-S, DHS050319A4-S, DHS051520A1R1-S, DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, DHS052220A1R1-S, DHS052720C1R1-S, DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, DHS060320C1R1-S, DHS060520C1R1-S, DHS060520F1R1-S, DHS060820E1R1-S, DHS061220A1R1-S, DHS061920B1R1-S, DHS062320B1R1-S, DHS062420B1R1-S, DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, DHS080219A1-S and 9 more |
| Expiration dates | 2021-05-15, 2021-05-29, 2021-05-30, 2021-06-03, 2021-06-30, 2021-08-02, 2021-09-02, 2021-10-18, 2022-04-28, 2022-06-15, 2022-06-20, 2022-06-22, 2022-06-27, 2022-06-29, 2022-07-03, 2022-07-05, 2022-07-08, 2022-07-12, 2022-07-19, 2022-07-23, 2022-07-24, 2022-09-11, 2022-09-12, 2022-09-14, 2022-09-17 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0658-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.