D-1412-2020 Class II Terminated
FDA drug recall D-1412-2020 was initiated by POLARIZED LLC on June 25, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol. The recall status is terminated (terminated December 2, 2020). Affected quantity: 18, 126 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 5, 2020
- Initiation Date
- June 25, 2020
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18, 126 bottles
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.
Reason for Recall
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Distribution Pattern
Distributed in VA with potential for Nationwide distribution in USA
Code Information
Lot # all lots to include 53131626