Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
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. The hazard involves a facility associated with methanol contamination, a toxic substance that can cause serious injury or death, fitting the 'Severe' criteria for significant injury risk or high-risk contamination.
Plain-English summary
4e Brands North America, LLC is recalling Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70% Natural Boost with Tea Tree Oil. The product is packaged in 18 fl oz and 33.8 fl oz bottles and was distributed nationwide in the USA and in Canada. The recall involves 17,359,247 total bottles and pumps.
The recall was initiated because the product was manufactured in the same facility as a product found to contain methanol. This situation represents poor Current Good Manufacturing Practices (CGMP). The source text does not specify if the recalled hand sanitizer itself was tested for or found to contain methanol, only that it shares a manufacturing facility with a contaminated product.
Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions. The recall number is D-0022-2021.
The recalled product
- Product
- blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamer
- 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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