Saniderm Hand Sanitizer Recalled for Undeclared Methanol and Low Ethanol
Polarized LLC is recalling Saniderm Advanced Hand Sanitizer because it contains undeclared methanol and less ethanol than labeled.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of undeclared methanol in a topical product poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Polarized LLC is recalling Saniderm Advanced Hand Sanitizer, 70% Alcohol Content, 1 Liter bottles. The recall involves 18, 126 bottles distributed in Virginia, with potential for nationwide distribution in the United States. The product is produced by Eskbiochem SA de CV in Mexico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing revealed that the product contained less ethanol than the label claim and included undeclared methanol. Methanol is a toxic substance that can cause serious health effects if absorbed through the skin or ingested.
Consumers who have purchased this product should stop using it immediately. The specific lot number is not limited to a single batch; the recall includes all lots, including lot number 53131626. The product can be identified by the UPC 8 60003 63391 5.
The recalled product
- Product
- Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
- Manufacturer
- POLARIZED LLC
- Category
- Drug — Hand Sanitizer
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 (1)
- Lot # all lots to include 53131626
Distribution
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