Option Systems Antibacterial Foaming Hand Wash with — Class II drug recall D-0864-2018
Terminated recall by Inopak Ltd, reported 2018-06-20, distributed nationwide. Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total ae
| Recall number | D-0864-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inopak Ltd, Ringwood, NJ, United States |
| Recall initiated | 2018-05-16 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,345 cases |
| Reason classes | microbial contamination, sterility, specification failure |
Product
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Reason for recall
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
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-0864-2018. 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.