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Class II: temporary or reversible health riskTerminated

Vi-Jon Topical Solution Hydrogen Peroxide First Aid Recall

Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl

Vi-Jon, Inc. · Smyrna, TN

Risk level
Class II
Reported by FDA
Mar 13, 2019
Recall ID
D-0520-2019
Check your lot numberHow we source this data

Summary

Vi-Jon recalled Topical Solution Hydrogen Peroxide First Aid starting Feb 20, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0520-2019 on Mar 13, 2019. Reason: Cross Contamination: Presence of IPA in finished product. Status: Terminated.

Why it was recalled

Cross Contamination: Presence of IPA in finished product.

Product description

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

Lot numbers, UPCs & expiration codes

Lot: 0384244 Exp. 01/2020

Where it was sold

Distributed in Ohio

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0520-2019
Classification
Class II
Status
Terminated
Recall initiated
Feb 20, 2019
FDA report date
Mar 13, 2019
Quantity
6756 32 oz bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Vi-Jon, Inc.

Original FDA data

Every field from FDA enforcement report D-0520-2019, exactly as published.

Show all FDA fields
City
Smyrna
State
TN
Status
Terminated
Country
United States
Event ID
82215
Address
1 Swan Dr
Code information
Lot: 0384244 Exp. 01/2020
Postal code
37167-2099
Report date
Mar 13, 2019
Product type
Drugs
Recall number
D-0520-2019
Classification
Class II
Recalling firm
Vi-Jon, Inc.
Product quantity
6756 32 oz bottles
Termination date
May 8, 2020
Reason for recall
Cross Contamination: Presence of IPA in finished product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed in Ohio
Recall initiation date
Feb 20, 2019
Initial firm notification
Letter
Center classification date
Mar 7, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0520-2019, published Mar 13, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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