Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Cross Contamination: Presence of IPA in finished product.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
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 NDC
53943-0871-45
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Vi-Jon, Inc.
- NDC code
- 53943-871-45
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0520-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Vi-Jon, Inc.
All 2019 recalls
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Other cross-contamination recalls from 2019
All cross-contamination recalls
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class II · Moderate risk
Petroleum jelly
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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