Drug product
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
D-0078-2021
Product summary
- Event
- Event 86162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,441,548 bottles
- Official record key
drug-enforcement:D-0078-2021
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: all lots
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations