Recalls / Class II
Class IID-0022-2021
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, 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
- All lots within expiry
Why it was recalled
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
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-0022-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.