June 2020 FDA Recall Drug by Uvt Inc
D-1407-2020 - Chemical Contamination

This Class I drug recall was voluntarily initiated by Uvt Inc on June 22, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1407-2020

Reason for Recall
Chemical Contamination: Product contains undeclared methanol.
Initiated
06-22-2020
Reported
08-05-2020
Quantity
38,016 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85942
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
UVT INC
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to two wholesalers in FL who may have further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-28-2023
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# Lot 0530, Exp. Date 04/22