CLASS II Drug recall · Reported 13 Mar 2019 · FDA Enforcement Report
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic recalled
Vi-Jon is recalling Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent, distributed in Ohio. The recall was initiated on 20 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0520-2019
- FDA event ID
- 82215
- Recalling firm
- Vi-Jon, Smyrna, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2019
- FDA classified
- 7 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 20 Feb 2019 | Recall initiated by company | |
| 7 Mar 2019 | Classified by FDA | +15 days |
| 13 Mar 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination: Presence of IPA in finished product.
Product as listed by the FDA
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
Where it was distributed
Distributed in Ohio
Questions about this recall
Why was it recalled?
Cross Contamination: Presence of IPA in finished product.
Which lots are affected?
Lot: 0384244 Exp. 01/2020
Where was it sold?
Distributed in Ohio
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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