The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1311-2019·Announced 2019-06-05

Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations

Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text cites CGMP deviations without reporting specific illnesses or injuries, aligning with a Moderate severity rating for a voluntary precautionary recall.

Plain-English summary

Inopak Ltd is voluntarily recalling specific batches of AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w). The affected products are packaged in 18 FL OZ (532 mL) bottles (Product Code BIO-5075-432-02) and 1000 ML pouches (Product Code BIO575-OS1000). The recall involves Batch #6736 and Batch #6826, 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 products were distributed nationwide in the USA.

Consumers should check their inventory for the specific product codes and batch numbers listed above. If you have these products, you should stop using them and contact Inopak Ltd for further instructions or a refund.

The recalled product

Product
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000…
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 #: 6736
  • 6826

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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