ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bot...
FDA Drug Recall #D-812-2013 — Class III — July 18, 2013
Recall Summary
| Recall Number | D-812-2013 |
| Classification | Class III — Low risk |
| Date Initiated | July 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vi-Jon, Inc. |
| Location | Smyrna, TN |
| Product Type | Drugs |
| Quantity | 18,408 bottles |
Product Description
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
Reason for Recall
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 0185828, Exp 12/14
Other Recalls from Vi-Jon, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0644-2022 | Class II | HEB 50% Isopropyl Alcohol First Aid Antiseptic,... | Mar 2, 2022 |
| D-0799-2021 | Class II | Kroger 70% Isopropyl Alcohol First Aid Antisept... | Sep 9, 2021 |
| D-0520-2019 | Class II | Topical Solution USP Hydrogen Peroxide First Ai... | Feb 20, 2019 |
| D-0006-2018 | Class III | Magnesium Citrate Oral Solution Cherry Flavor, ... | Sep 13, 2017 |
| D-0073-2018 | Class III | Equate Beauty Clarifying Face Daily Moisturizer... | Sep 13, 2017 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.