The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1317-2019·Announced 2019-06-05

Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer 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 but does not report specific illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Inopak Ltd is voluntarily recalling Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%. The product is packaged in 1000 ml pouches and cartridge pouches. The recall involves batches 6668 and 6721, with a quantity of 17,850 pounds per batch.

The recall was initiated because the hand sanitizers were not produced under current good manufacturing practices (CGMP). The product was distributed nationwide in the USA.

Consumers who have this product should stop using it and contact Inopak Ltd for further instructions.

The recalled product

Product
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
Manufacturer
Inopak Ltd
Category
Drug — Hand Sanitizer
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 (2)

  • Batch #: 6668
  • 6721

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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