Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each…
Reason Lack of Assurance of Sterility
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Incorrect/Undeclared Excipients.
What was recalled
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
- Recalling firm
- Vi-Jon, LLC
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1173-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Menthol recalls
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Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ…
Reason Lack of Assurance of Sterility
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