September 2021 FDA Recall 70% Isopropyl Rubbing Alcohol by Vi-jon, Inc.
D-0799-2021 - Labeling

This Class II drug recall was voluntarily initiated by Vi-jon, Inc. on September 9, 2021 for the product 70% Isopropyl Rubbing Alcohol. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0799-2021

Reason for Recall
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Initiated
09-09-2021
Reported
09-22-2021
Quantity
21,156 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88653
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.
Vi-Jon, 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 Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2023
Product Description About Product Description
Full technical description of the product.
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049

Batch or Lot Expiration Information

Lot# Lot: 0542077 Exp. 07/2023

Affected Packages Involved in this Recall

30142-810-72 70% Isopropyl Rubbing Alcohol
30142-810-43 70% Isopropyl Rubbing Alcohol
30142-810-45 70% Isopropyl Rubbing Alcohol
30142-810-14 70% Isopropyl Rubbing Alcohol