Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing 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 and involves a facility associated with methanol contamination, a toxic substance, which aligns with the 'Severe' criteria for significant hazard potential.
Plain-English summary
4e Brands North America, LLC is recalling Blumen Aloe Advanced Hand Sanitizer, 70% alcohol content, 3.4 fl. oz./100 mL bottles. The product was distributed nationwide in the USA and in Canada. The recall involves 17,359,247 total bottles and pumps, with all lots within expiry.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the product was manufactured in the same facility as a product found to contain methanol. This association represents poor manufacturing practices.
Consumers should stop using the product and follow instructions from the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
- 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
Same manufacturer · 4e Brands North America, Llc
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FDA (Drugs) · 2020-10-07
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- SevereASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
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