Drug 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.
D-0031-2021
Product summary
- Event
- Event 86022
- Status
- Terminated
- Classification
- Class I
- Quantity
- 17,359,247 total bottles and pumps
- Official record key
drug-enforcement:D-0031-2021
Official wording
Reason: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Code information: Lot #: a) 2141, Exp 04/40/23; 2879, Exp 04/23/23; 3005, Exp 05/08/23; b) 2911, Exp 04/23/23
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination
-
Potency or specification failure
Subpotent