The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1314-2019·Announced 2019-06-05

Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash 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 and involves CGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouches. The product is identified by NDC 058575-110-11 and NDC 058575-110-80, and includes batch numbers 7304, 7180, 6707, and 7065.

The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). The agency has classified this recall as Class II.

The affected product was distributed nationwide in the USA. Consumers should stop using the product and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
Manufacturer
Inopak Ltd
Category
Drug — Hand Sanitizer / Soap
Hazard

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 (4)

  • Batch #: 7304
  • 7180
  • 6707
  • 7065

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 →

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