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D-1310-2019 Class II Terminated

Recalled by Inopak Ltd — Ringwood, NJ

FDA drug recall D-1310-2019 was initiated by Inopak Ltd on Apr 22, 2019 and is designated Class II. Reason for recall: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. The recall status is terminated (terminated Aug 28, 2024). Affected quantity: 17,850 pounds per batch.

Recall Details

Product Type: Drugs
Report Date: Jun 5, 2019
Initiation Date: Apr 22, 2019
Termination Date: Aug 28, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,850 pounds per batch

Product Description

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.

Distribution Pattern

Nationwide in the USA

Code Information

Batch #: 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, 7033, 7039, 7043, 7053, 7060, 7068, 7080, 7092, 7101, 7110, 7116, 7126, 7143, 7153, 7161, 7167, 7175, 7188, 7204, 7208, 7213, 7221, 7232, 7242, 7248, 7267, 7275, 7284, 7287, 7295, 7308, 7314, 7324, 7329, 7336, 7348, 7357, 7363, 7372, 7382, 7389, 7397, 7403, and 7411

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1310-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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