mdi Consultants
FDA MedWatch Alert – July 14, 2020
Hand Sanitizers by 4e Brands North America:
Recall Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
The company 4e Brands North America, based out of San Antonio, Texas, issued a nationwide voluntary recall of hand sanitizer due to the potential presence of undeclared methanol (wood alcohol) on July 11, 2020. The FDA was made aware of this recall through their MedWatch Adverse Event Reporting program and are sharing the recall announcement through their website on July 13, 2020.
4e Brands North America is recalling 10 bottle sizes of advanced and clear advanced hand sanitizers. The products are:
- BLUMEN Advanced Instant Hand Sanitizer Clear
- BLUMEN Advanced Hand Sanitizer
- BLUMEN Clear LEAR Advanced Hand Sanitizer
- BLUMEN Clear Advanced Hand Sanitizer
- BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol
Currently, 4e Brands North America has not received reports of adverse events related to this recall.
FDA is sharing this as a warning to consumers and health care providers that there has been a sharp increase in hand sanitizer products labeled to contain ethanol but have also tested positive for methanol contamination. For the full recall update, as well as the lot numbers, UPC and sizes associated to the product recall, please visit the FDA’s website.
This is not a surprise as companies are shipping these products without oversight by the FDA and FDA inspections. The FDA allows companies to register and list their alcohol hand sanitizers with no testing or inspections. We suspect the tests types of situations will cause the FDA to look closely to what is coming into the country and from where. More testing will be done by the FDA imports branch
For any further questions related to this update or about the FDA’s MedWatch Adverse Event Reporting program, please email mdi Consultants at [email protected] RE: MedWatch.