← FDA ENFORCEMENT
D-1173-2023Class III

Vi-Jon, LLC

Recalling firm
Vi-Jon, LLC
Product type
Drug
Status
Terminated
Report date
2023-09-27
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.
Firm state
TN
Product quantity
245,904 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Incorrect/Undeclared Excipients.

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

Code / lot info

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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.