FDARecalled Jul 29, 2026 · #D-0722-2026
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made i...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility Classification: Class II Distribution: Nationwide within the United States
Product details
- Product
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
- Type
- Drugs
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Model numbers
- 3J1V
- UPCs
- —