FDA-Drug2019-06-05Class II

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.

Inopak Ltd
Hazard

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Sold states
Nationwide in the USA
Affected count
17,850 pounds per batch
Manufactured in
24 Executive Pkwy, N/A, Ringwood, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1313-2019

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