Antibacterial Hand Soap — Class II drug recall D-1318-2019
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-1318-2019 |
|---|---|
| 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 | 6660, 6664, 6676, 6682, 6685, 6698, 6701, 6725, 6732, 6742, 6744, 6746, 6756, 6762, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6820, 6829, 6839, 6868, 6872, 6875, 6891, 6892, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6952, 6958, 6963, 6970 and 69 more |
Product
Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ.
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-1318-2019. 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.