Lewes, DE, United States
POLARIZED LLC recalls
1 recall recorded since 2018, most recently on 25 June 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 25 June 2020
- Terminated
- 2 December 2020
- Reason
- CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
- Distribution
- Distributed in VA with potential for Nationwide distribution in USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1412-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.