Recalls / Class I
Class ID-0030-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7
- Affected lot / code info
- Lot #: 2221, Exp 04/09/23; 2252, Exp 04/12/23
Why it was recalled
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Recalling firm
- Firm
- 4e Brands North America, Llc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 17806 Ih-10 Ste 300, N/A, San Antonio, Texas 78257
Distribution
- Quantity
- N/A
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-07-11
- FDA classified
- 2020-10-07
- Posted by FDA
- 2020-10-07
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0030-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.