The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1319-2019·Announced 2019-06-05

Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations

Inopak Ltd is recalling Unison Hand Care Products due to production not meeting 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 situation where use of the product may cause temporary or medically reversible health consequences. The source text cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall based on manufacturing standards.

Plain-English summary

Inopak Ltd is recalling Unison Hand Care Products, specifically the White Pearlized Anti-Bacterial Hand Cleaner with Triclosan, #4302. The affected product is packaged in 800 ml (27 fl oz) pouch containers, with 12 containers per case. The recall involves Batch # 6827, with a quantity of 17,850 pounds per batch.

The recall was initiated because the hand sanitizers and soaps were not produced under current good manufacturing practices (CGMP). This deviation from required manufacturing standards necessitates the removal of the product from the market.

The product was distributed nationwide in the USA. Consumers who possess this specific batch of Unison Hand Care Products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401…
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 (1)

  • Batch # 6827

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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