ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as… — Class II drug recall D-1310-2019
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-1310-2019 |
|---|---|
| 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 | 6657, 6666, 6671, 6679, 6687, 6695, 6702, 6718, 6730, 6744, 6754, 6760, 6772, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6856, 6862, 6877, 6890, 6896, 6902, 6910, 6919, 6938, 6944, 6953, 6971, 6985, 6990, 6998, 7005, 7012, 7018, 7028 and 44 more |
Product
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, 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-1310-2019. 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.