Recalls / Class III
Class IIID-1173-2023
Product
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
- Affected lot / code info
- 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.
Why it was recalled
Incorrect/Undeclared Excipients.
Recalling firm
- Firm
- Vi-Jon, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 1 Swan Dr, Smyrna, Tennessee 37167-2099
Distribution
- Quantity
- 245,904 Bottles
- 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.
Timeline
- Recall initiated
- 2023-09-05
- FDA classified
- 2023-09-21
- Posted by FDA
- 2023-09-27
- Terminated
- 2025-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1173-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.