March 2022 FDA Recall Drug by Vi-jon, Inc.
D-0644-2022 - Labeling

This Class II drug recall was voluntarily initiated by Vi-jon, Inc. on March 2, 2022 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed to one distributor in Texas for further distribution and the recall is currently terminated.

Recall Number: D-0644-2022

Reason for Recall
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% 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. The back label is correct. Product is packaged in dark bottles.
Initiated
03-02-2022
Reported
03-09-2022
Quantity
11,580 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89706
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.
Product was distributed to one distributor in Texas for further distribution
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7

Batch or Lot Expiration Information

Lot# Lot: 0546089 Exp. 09/2023