Drug product
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
D-0363-2022
Product summary
- Firm
- Valisa MFG LLC
- Event
- Event 89186
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7704 bottles
- Official record key
drug-enforcement:D-0363-2022
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Code information: Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
contain methanol