Food, drugs, devices › Inopak Ltd
Drug recall: Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
FDA enforcement event 80196 is a drug recall by Inopak Ltd of Ringwood, NJ, initiated 16 May 2018 and classified Class II, with 1 product record.
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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 23 Oct 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
"Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0864-2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ | 1345 cases | Class II | Terminated | 20 Jun 2018 |
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 |
| 23 Aug 2017 | 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 | Drug | Class II | 3 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts"
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 23 Oct 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.