February 2019 FDA Recall Drug by Vi-jon, Inc.
D-0520-2019 - Cross Contamination
This Class II drug recall was voluntarily initiated by Vi-jon, Inc. on February 20, 2019 for the product Drug. The FDA reported the reason for recall as cross contamination. The product was distributed in Distributed in Ohio and the recall is currently terminated.
Recall Number: D-0520-2019
Cross Contamination: Presence of IPA in finished product.
02-20-2019
03-13-2019
6756 32 oz bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed in Ohio
05-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8
Batch or Lot Expiration Information
Lot# Lot: 0384244 Exp. 01/2020
