Why it was recalled
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # all lots to include 53131626
Where it was sold
Distributed in VA with potential for Nationwide distribution in USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1412-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 25, 2020
- FDA report date
- Aug 5, 2020
- Quantity
- 18, 126 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- POLARIZED LLC
Original FDA data
Every field from FDA enforcement report D-1412-2020, exactly as published.
Show all FDA fields
- City
- Lewes
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 85944
- Address
- 16192 Coastal Hwy
- Code information
- Lot # all lots to include 53131626
- Postal code
- 19958-3608
- Report date
- Aug 5, 2020
- Product type
- Drugs
- Recall number
- D-1412-2020
- Classification
- Class II
- Recalling firm
- POLARIZED LLC
- Product quantity
- 18, 126 bottles
- Termination date
- Dec 2, 2020
- Reason for recall
- CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed in VA with potential for Nationwide distribution in USA
- Recall initiation date
- Jun 25, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jul 28, 2020