Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%
Rohto-Mentholatum (Vietnam) Co., Ltd. has initiated a Class II recall for Rohto Cooling Eye Drops Cool Relief due to a lack of assurance of sterility. The recall involves 0.4 FL OZ (13 mL) containers distributed by The Mentholatum Company.
This affects Rohto-Mentholatum (Vietnam) Co., Ltd., The Mentholatum Company, and distributors or retailers handling the specific NDC 10742-8141-1. It also impacts regulatory and quality professionals overseeing sterile ophthalmic manufacturing.
A lack of sterility assurance in ophthalmic products presents a significant safety risk, as non-sterile eye drops can lead to serious infections. For regulatory professionals, this Class II designation suggests that while the risk may not be immediate or life-threatening (Class I), the manufacturing process failed to meet required aseptic standards, potentially necessitating a review of site-specific sterilization validation and controls.
Quality teams should verify the sterility assurance levels and environmental monitoring data for ophthalmic products manufactured at the identified site. Supply chain managers should identify and quarantine affected NDC and UPC lots to prevent further distribution.
Class II. Reason: Lack of Assurance of Sterility. 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. Firm: Rohto-Mentholatum (Vietnam) Co., Ltd. (Ho Chi Minh N/A Vietnam). Status: Ongoing.
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