Recalls / Class II
Class IID-0520-2019
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
- Affected lot / code info
- Lot: 0384244 Exp. 01/2020
Why it was recalled
Cross Contamination: Presence of IPA in finished product.
Recalling firm
- Firm
- Vi-Jon, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, N/A, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 6756 32 oz bottles
- Distribution pattern
- Distributed in Ohio
Timeline
- Recall initiated
- 2019-02-20
- FDA classified
- 2019-03-07
- Posted by FDA
- 2019-03-13
- Terminated
- 2020-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0520-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.