Drug product
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
D-0080-2021
Product summary
- Event
- Event 86162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27,000 bottles
- Official record key
drug-enforcement:D-0080-2021
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: 1931102AL
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
found to contain methanol
-
Manufacturing or process control
CGMP Deviations