Premium Nature Instant Hand Sanitizer Recalled for Subpotent Ethanol Content
Premium Nature Instant Hand Sanitizer is being recalled nationwide because some bottles were found to contain subpotent levels of ethanol. The FDA identified the issue during analysis of multiple bottle sizes.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect (subpotent active ingredient) that reduces effectiveness but does not pose an acute safety threat. No hospitalization or serious injury has been reported.
Plain-English summary
Premium Nature Instant Hand Sanitizer, manufactured by AMS Packaging Inc and distributed nationwide, is being recalled due to subpotency of the active ingredient. FDA analysis revealed that some bottles of this product contained lower than labeled ethanol concentration.
The affected product is sold in multiple sizes: 2 OZ (60 ML), 4 OZ (118 ML), 16 OZ (473 ML), and 1 gallon bottles. All lots within expiry that are labeled "Made in the USA" are included in this recall.
Consumers who have purchased this product should stop using it and contact the manufacturer or retailer for further instructions. The subpotent formulation means the hand sanitizer may not provide the intended level of antimicrobial protection.
The recalled product
- Product
- Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
- Manufacturer
- AMS Packaging Inc
- Category
- Drug — Topical / Hand Sanitizer
- Hazard
- subpotent-active-ingredient
- reduced-efficacy
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)
- All lots within expiry and labelled as 'Made in the USA'
Distribution
Distributed nationwide across the United States.
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