D-1173-2023 Class III Terminated
FDA drug recall D-1173-2023 was initiated by Vi-Jon, LLC on September 5, 2023 and is designated Class III. Reason for recall: Incorrect/Undeclared Excipients. The recall status is terminated (terminated January 29, 2025). Affected quantity: 245,904 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 27, 2023
- Initiation Date
- September 5, 2023
- Termination Date
- January 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 245,904 Bottles
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
Reason for Recall
Incorrect/Undeclared Excipients.
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.
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.