Recalls / Class I
Class ID-0031-2021
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 HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
- Affected lot / code info
- Lot #: a) 2141, Exp 04/40/23; 2879, Exp 04/23/23; 3005, Exp 05/08/23; b) 2911, Exp 04/23/23
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
- 17,359,247 total bottles and pumps
- 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-0031-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.