Drug 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.
D-0024-2021
Product summary
- Event
- Event 86022
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,359,247 total bottles and pumps
- Official record key
drug-enforcement:D-0024-2021
Official wording
Reason: 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.
Code information: All lots within expiry.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations