Drug 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
D-1173-2023
Product summary
- Firm
- Vi-Jon, LLC
- Event
- Event 93001
- Status
- Terminated
- Classification
- Class III
- Quantity
- 245,904 Bottles
- Official record key
drug-enforcement:D-1173-2023
Official wording
Reason: Incorrect/Undeclared Excipients.
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.
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.
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients.