kleantouch Hand Sanitizer recalled for methanol contamination
Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which per the rubric criteria requires a minimum score of 4. Methanol in hand sanitizer products poses a serious and direct health hazard, and the unapproved drug status combined with a known toxic ingredient elevates this to Critical.
Plain-English summary
Valisa MFG LLC is recalling kleantouch Hand Sanitizer (ethyl alcohol 70%), sold in 8.0 FL OZ (236 ML) pump bottles, distributed nationwide in the USA. The product is identified by UPC 6 86162 99246 1. Affected lot numbers are 1260-1, 1260-2, 1260-3, and 1260-4, with expiration date 04/2022.
The product was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains methanol, which makes it an unapproved new drug under FDA regulations.
Consumers who have purchased this hand sanitizer should stop using it immediately and dispose of it safely. Anyone with questions about the recall should contact Valisa MFG LLC, located in Farmingdale, NY.
The recalled product
- 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
- Manufacturer
- Valisa MFG LLC
- Category
- Drug — Hand Sanitizer
- Affected units
- 7,704
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 1260-1
- 1260-2
- 1260-3
- 1260-4. Exp. 04/2022
Distribution
Distributed nationwide across the United States.
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