Why it was recalled
Incorrect/Undeclared Excipients.
Product description
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
Lot numbers, UPCs & expiration codes
Lot #: 0589344, 0589626, 0589678, Exp. Date 01/02/2025; 0594596, Exp. Date 03/08/2025; 0595970, Exp. Date 04/13/2025; 0597832, Exp. Date 04/30/2025; 0601219, Exp. Date 06/26/2025; 0601488, Exp. Date 05/16/2025; 0604129, Exp. Date 07/18/2025.
Where it was sold
The consignee list includes one distributor with seven distribution centers. No product was sold under government contract. No product was sold to any federal, state, or local agency in the school lunch program.
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-1173-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 5, 2023
- FDA report date
- Sep 27, 2023
- Quantity
- 245,904 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vi-Jon, LLC
Original FDA data
Every field from FDA enforcement report D-1173-2023, exactly as published.
Show all FDA fields
- City
- Smyrna
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 93001
- Address
- 1 Swan Dr
- Code information
- Lot #: 0589344, 0589626, 0589678, Exp. Date 01/02/2025; 0594596, Exp. Date 03/08/2025; 0595970, Exp. Date 04/13/2025; 0597832, Exp. Date 04/30/2025; 0601219, Exp. Date 06/26/2025; 0601488, Exp. Date 05/16/2025; 0604129, Exp. Date 07/18/2025.
- Postal code
- 37167-2099
- Report date
- Sep 27, 2023
- Product type
- Drugs
- Recall number
- D-1173-2023
- Classification
- Class III
- Recalling firm
- Vi-Jon, LLC
- Product quantity
- 245,904 Bottles
- Termination date
- Jan 29, 2025
- Reason for recall
- Incorrect/Undeclared Excipients.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
- Distribution pattern
- The consignee list includes one distributor with seven distribution centers. No product was sold under government contract. No product was sold to any federal, state, or local agency in the school lunch program.
- Recall initiation date
- Sep 5, 2023
- Initial firm notification
- Telephone
- Center classification date
- Sep 21, 2023