ALCOHOL FREE ANTISEPTIC — Class III drug recall D-812-2013
Terminated recall by Vi-Jon, Inc., reported 2013-07-31, distributed nationwide. Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was
| Recall number | D-812-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vi-Jon, Inc., Smyrna, TN, United States |
| Recall initiated | 2013-07-18 |
| Classified | 2013-07-22 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 18,408 bottles |
| Reason classes | microbial contamination, sterility, specification failure |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00041260336065 |
| Lot numbers | 0185828, 12/14 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-812-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.