FDA Recall D-0363-2022
Valisa MFG LLC · Farmingdale, NY
Class I — life-threatening Terminated 812 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Recall record
- Recall number
D-0363-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2021-12-06
- Classified by FDA Center
- 2022-01-10
- FDA published
- 2022-01-05
- Terminated
- 2024-02-26
- Recalling firm
- Valisa MFG LLC
- Firm location
- Farmingdale, NY