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.
Recall initiated: 20190422
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated