June 2020 FDA Recall Drug by Polarized Llc
D-1412-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Polarized Llc on June 25, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1412-2020

Reason for Recall
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Initiated
06-25-2020
Reported
08-05-2020
Quantity
18, 126 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85944
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
POLARIZED LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in VA with potential for Nationwide distribution in USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# all lots to include 53131626