Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations
Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites CGMP deviations and labeling errors but does not report specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary or precautionary recall.
Plain-English summary
Inopak Ltd is recalling Inoderm Antiseptic Hand Soap (E-2) in 800ml/27fl.oz. pouches. The product is identified by Batch # 7074 and NDC 058575-110. The recall covers 17,850 pounds per batch, distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the hand sanitizers and soaps were not produced under current good manufacturing practices. The source text notes that the product is incorrectly labeled on bags as 75% PCMX, whereas the product name indicates .6% PCMX.
Consumers should stop using the recalled product and contact the recalling firm for further instructions. The agency classification for this recall is Class II.
The recalled product
- 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.
- Manufacturer
- Inopak Ltd
- Category
- Drug — Topical Antiseptic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch #: 7074
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Inopak Ltd under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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