Nearly 12 Million Eye Drops Recalled Nationwide

The U.S. Food and Drug Administration classified a nationwide recall of 11,960,623 cartons of Rohto Cooling Eye Drops as Class II in late July, according to the agency’s enforcement report. The recall was initiated voluntarily by Rohto-Mentholatum (Vietnam) Co., Ltd. and covers over-the-counter eye drops distributed across the United States. The FDA said the reason for the recall was a “lack of assurance of sterility,” a quality problem that can matter for products applied directly to the eye. Class II recalls are used for products that may cause temporary or medically reversible adverse health consequences, with serious harm considered less likely. ### Which eye drops are included in the recall? Eight Rohto Cooling Eye Drops products are included in the recall, according to reports that cited the FDA listing. The affected items include All-in-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief, with some products listed in both single-pack and twin-pack versions. (ophthalmologymanagement.com) The FDA enforcement entry cited by news outlets puts the total at 11,960,623 cartons distributed nationwide. Several reports described the products as bottles or cartons; the FDA enforcement system tracks recalled units by the packaging description listed in the report. ### What does “lack of assurance of sterility” mean here? (glance.eyesoneyecare.com) The FDA listed “lack of assurance of sterility” as the reason for the recall. For ophthalmic products, sterility is a basic safety requirement because contamination can expose users to potentially harmful microbes when drops are placed in the eye. The agency’s recall classification does not by itself mean confirmed injuries were reported in this case. (ophthalmologymanagement.com) The FDA’s enforcement report page says classifications are assigned after the agency reviews information provided in a recall and assesses the risk to public health. ### How serious is a Class II recall? The FDA defines a Class II recall as a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. (nbcchicago.com) That is the category the agency assigned to the Rohto eye-drop recall. (fda.gov) The classification is separate from the company’s decision to remove the product. The FDA says firms often begin voluntary recalls before the agency completes its formal classification and posts the action to the enforcement report. ### What should shoppers do if they have these drops at home? Consumers with Rohto Cooling Eye Drops covered by the recall should stop using them until they confirm whether their lot number is affected, according to reports citing the FDA listing. (nbcchicago.com) News reports on the recall said affected lot numbers were tied to specific recalled products and packaging configurations. (fda.gov) The FDA’s drug-recall page says recalls are actions taken by a firm to remove a defective product from the market or warn patients and consumers about a potential risk. The agency’s recall resources page and enforcement report database are the main federal sources for checking whether a specific medicine is covered. ### Where can people find the lot numbers and return instructions? (techtimes.com) The FDA’s enforcement report is the central federal record for recall classification, reason, and product description, and it is updated as recall information changes. The agency also says consumers can subscribe to recall notices by keyword or product category through the enforcement report system. (fda.gov) Company recall pages can provide return forms and instructions when a distributor posts them publicly. AvKARE, for example, says customers with affected recalled products should discontinue use, remove them from active inventory, and submit an electronic recall form or return paperwork when applicable. The FDA said recall data remain available through its weekly enforcement reports and searchable recall tools. (fda.gov) Consumers checking products now should use the product name, packaging type and lot number from the bottle or carton against the FDA listing and any manufacturer or distributor notice tied to the recall. (avkare.com)