Drug recall D-1173-2023

Class III Terminated reported Sep 27, 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

Reason for recall

Incorrect/Undeclared Excipients.

Lots and 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.

Recall details

Recalling firm
Vi-Jon, LLC, Smyrna, TN
Quantity
245,904 Bottles
Distribution
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.
Type
Voluntary: Firm initiated
Recall initiated
September 5, 2023
Terminated
January 29, 2025