FDA Recall D-0030-2021
4e Brands North America, Llc · San Antonio, TX
Class I — life-threatening Terminated 1325 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Recall record
- Recall number
D-0030-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2020-07-11
- Classified by FDA Center
- 2020-10-07
- FDA published
- 2020-10-07
- Terminated
- 2024-02-26
- Recalling firm
- 4e Brands North America, Llc
- Firm location
- San Antonio, TX