Recall record at a glance
| Official record | D-812-2013 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Vi-Jon, Inc. |
| Report date | Jul 31, 2013 |
| Recall initiation date | Jul 18, 2013 |
| Quantity | 18,408 bottles |
| Location | Smyrna, TN, United States |
Official 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.
Why the product was recalled
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Distribution information
Nationwide
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.