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