Drug product
LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
D-1582-2020
Product summary
- Event
- Event 86105
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90,288 bottles
- Official record key
drug-enforcement:D-1582-2020
Official wording
Reason: CGMP Deviations: Born Basic Anti Bac 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: 0133920, 0233920, 0333920
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