Drug product
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6
D-0079-2021
Product summary
- Event
- Event 86162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,760 bottles
- Official record key
drug-enforcement:D-0079-2021
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: 1931104AL
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations