Recalls / Class II
Class IID-0024-2021
Product
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL / 4L bottle, UPC 8 14266 02368 6; 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-0024-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.