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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 0185828, Exp 12/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-812-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 18,408 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vi-Jon, Inc.
Original FDA data
Every field from FDA enforcement report D-812-2013, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 65761
- Address
- 1 Swan Dr.
- Code information
- Lot #: 0185828, Exp 12/14
- Postal code
- 37167-2099
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-812-2013
- Classification
- Class III
- Recalling firm
- Vi-Jon, Inc.
- Product quantity
- 18,408 bottles
- Termination date
- Jun 17, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 22, 2013