FDA recall D-1313-2019

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-22

Report date

2019-06-05

Termination date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ringwood, NJ, United States

Primary source

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