Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2
Rohto-Mentholatum (Vietnam) Co., Ltd. has initiated a Class II recall for Rohto Cooling Eye Drops Max Strength due to a lack of assurance of sterility. The recall affects 13 mL units distributed by The Mentholatum Company under NDC 10742-8158-1.
This affects Rohto-Mentholatum (Vietnam) Co., Ltd., The Mentholatum Company, and professionals involved in the quality oversight, distribution, and clinical use of ophthalmic drug products.
A lack of sterility assurance in ophthalmic products presents a significant risk as these drugs are intended for use in the eye where contamination can lead to serious infections. A Class II designation suggests that while the risk of permanent injury is lower than Class I, the product does not meet the necessary regulatory requirements for sterile manufacturing, potentially indicating systemic issues in the production environment or validation processes.
QA teams should verify if any current inventory is affected by this specific NDC and UPC. Supply chain and regulatory personnel should review the sterilization validation documentation for products manufactured at this site to ensure compliance with sterility assurance levels.
Class II. Reason: Lack of Assurance of Sterility. Product: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1. Firm: Rohto-Mentholatum (Vietnam) Co., Ltd. (Ho Chi Minh N/A Vietnam). Status: Ongoing.
Open in openFDA / FDA.gov