Drug product
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
D-0028-2021
Product summary
- Event
- Event 86022
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,359,247 total bottles and pumps
- Official record key
drug-enforcement:D-0028-2021
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