INODERM Antiseptic Hand Soap — Class II drug recall D-1313-2019
Terminated recall by Inopak Ltd, reported 2019-06-05, distributed nationwide. CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
| Recall number | D-1313-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inopak Ltd, Ringwood, NJ, United States |
| Recall initiated | 2019-04-22 |
| Classified | 2019-05-29 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 17,850 pounds |
| Reason classes | cgmp |
| Lot numbers | 7074 |
Product
INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
Reason for recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
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-1313-2019. 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.