Antibacterial Foaming Hand Wash (Inopak Ltd) – Manufacturing Deviation (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, In
Brand
Inopak Ltd
Lot Codes / Batch Numbers
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
Products Sold
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
Inopak Ltd is recalling ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C. due to CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026