Drug product
NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3
D-0082-2021
Product summary
- Event
- Event 86162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,598,788 bottles
- Official record key
drug-enforcement:D-0082-2021
Official wording
Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Code information: Lots ending in 1001,1002, 1003, 1004, 1005.
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations