Recalls / Class III
Class IIID-812-2013
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.
- Affected lot / code info
- Lot #: 0185828, Exp 12/14
Why it 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.
Recalling firm
- Firm
- Vi-Jon, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr., N/A, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 18,408 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-18
- FDA classified
- 2013-07-22
- Posted by FDA
- 2013-07-31
- Terminated
- 2014-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-812-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.