September 2023 FDA Recall Drug by Vi-jon, Llc
D-1173-2023 - Incorrect/Undeclared Excipients.

This Class III drug recall was voluntarily initiated by Vi-jon, Llc on September 5, 2023 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipients.. The product was distributed in 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. and the recall is currently terminated.

Recall Number: D-1173-2023

Reason for Recall
Incorrect/Undeclared Excipients.
Initiated
09-05-2023
Reported
09-27-2023
Quantity
245,904 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93001
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Vi-Jon, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial 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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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.