Drug 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.
D-812-2013
Product summary
- Firm
- Vi-Jon, Inc.
- Event
- Event 65761
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,408 bottles
- Official record key
drug-enforcement:D-812-2013
Official wording
Reason: Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Code information: Lot #: 0185828, Exp 12/14
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination