Assured Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Assured Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMP practices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the presence of methanol (a toxic substance) in the same facility triggers a higher severity rating than a standard Class II without such specific toxicological risks, aligning with the 'Severe' criteria for significant potential harm.
Plain-English summary
4e Brands North America, Llc is recalling Assured Instant Hand Sanitizer Aloe & Moisturizers (70% ethyl alcohol). The product is distributed by Greenbrier International, Inc. and was distributed nationwide in the USA. The recall involves 17,359,247 total bottles and pumps, including 8 fL oz and 10 fL oz packages.
The recall was initiated because the product was manufactured in the same facility as a product found to contain methanol. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers should stop using the recalled product and contact the distributor or manufacturer for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in
- Manufacturer
- 4e Brands North America, Llc
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 17,359,247
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by 4e Brands North America, Llc 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 →Related recalls
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