Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0....

FDA Recall #D-1173-2023 — Class III — September 5, 2023

Recall #D-1173-2023 Date: September 5, 2023 Classification: Class III Status: Terminated

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.

Recalling Firm

Vi-Jon, LLC — Smyrna, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product 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.

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated