Drug product
scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
D-1579-2020
Product summary
- Event
- Event 86105
- Status
- Terminated
- Classification
- Class II
- Quantity
- 504,000 pieces
- Official record key
drug-enforcement:D-1579-2020
Official wording
Reason: CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Code information: Lots: 0133220, 0233220, 0333220, 0433220, 0533220, 0633220, 0733220, 0833220, 0933220, 1033220 1133220, 1233220, 1333220, 1433220, 1533220
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