September 2021 FDA Recall Drug by Sanitor Corporation
D-0018-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Sanitor Corporation on September 21, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed to one distributor located in Las Vegas, NV. and the recall is currently terminated.

Recall Number: D-0018-2022

Reason for Recall
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Initiated
09-21-2021
Reported
10-27-2021
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88754
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.
Sanitor Corporation
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to one distributor located in Las Vegas, NV.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-21-2023
Product Description About Product Description
Full technical description of the product.
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3

Batch or Lot Expiration Information

Lot# 20102, 20103, Exp, Sept, 2021