FDA recall D-1173-2023

Vi-Jon, LLC · Class III · drug

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.

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.

Key facts

Status
Terminated
Initiation date
2023-09-05
Report date
2023-09-27
Termination date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Smyrna, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1173-2023