Inopak Ltd
FDA Regulatory Profile
Inopak Ltd has 14 FDA recalls, 7 inspections, 0 510(k) clearances and 2 compliance actions on record.
- Latest recall
- D-1314-2019 · Class II · Apr 22, 2019
- Latest inspection
- Aug 3, 2023 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 14 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1314-2019 | Class II | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML… | Apr 22, 2019 |
| D-1313-2019 | Class II | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX… | Apr 22, 2019 |
| D-1315-2019 | Class II | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial… | Apr 22, 2019 |
| D-1311-2019 | Class II | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w)… | Apr 22, 2019 |
| D-1318-2019 | Class II | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a)… | Apr 22, 2019 |
| D-1319-2019 | Class II | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with… | Apr 22, 2019 |
| D-1316-2019 | Class II | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8… | Apr 22, 2019 |
| D-1310-2019 | Class II | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap… | Apr 22, 2019 |
| D-1312-2019 | Class II | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand… | Apr 22, 2019 |
| D-1317-2019 | Class II | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per… | Apr 22, 2019 |
| D-0864-2018 | Class II | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD… | May 16, 2018 |
| D-0003-2018 | Class II | Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL… | Aug 23, 2017 |
| D-0002-2018 | Class II | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and… | Aug 23, 2017 |
| D-0004-2018 | Class II | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD… | Aug 23, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 3, 2023 | Ringwood, NJ | Drugs | Official Action Indicated (OAI) | 1000122232 |
| Jun 18, 2021 | Ringwood, NJ | Drugs | Official Action Indicated (OAI) | 1000122232 |
| Jul 20, 2018 | Ringwood, NJ | Drugs | Official Action Indicated (OAI) | 1000122232 |
| Mar 24, 2017 | Ringwood, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000122232 |
| Feb 11, 2015 | Ringwood, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000122232 |
| Sep 11, 2012 | Ringwood, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000122232 |
| Aug 21, 2009 | Ringwood, NJ | Drugs | Voluntary Action Indicated (VAI) | 1000122232 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000122232 | Ringwood, NJ | 7 | Aug 3, 2023 |