Food, drugs, devices › Inopak Ltd
Drug recall: Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 100
FDA enforcement event 78098 is a drug recall by Inopak Ltd of Ringwood, NJ, initiated 23 Aug 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 20 Apr 2020. Initiation: voluntary: firm initiated. Inopak Ltd has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Inopak Ltd, Ringwood, NJ.
Reason for recall
"GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump."
Distribution
"nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0002-2018 | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02 | N/A | Class II | Terminated | 11 Oct 2017 |
| D-0003-2018 | Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456 | N/A | Class II | Terminated | 11 Oct 2017 |
| D-0004-2018 | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ | N/A | Class II | Terminated | 11 Oct 2017 |
Context
Other enforcement events for Inopak Ltd
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Apr 2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) | Drug | Class II | 10 |
| 16 May 2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ | Drug | Class II | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Apr 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.