WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the lot number and expiration date on the package before using the product. The U.S. Food and Drug Administration has classified a recall involving 12,460,649 bottles as Class II because the manufacturer cannot assure that affected products are sterile.
The recall covers eight Rohto Cooling Eye Drops varieties, including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief. Some products were sold as single bottles and others in twin packs. The FDA says only specific lots are affected, so the recall does not include every bottle of those products.
The products were sold over the counter nationwide. Rohto-Mentholatum initiated a voluntary recall, and The Mentholatum Company distributed the products. The products were manufactured in Vietnam.
What does “lack of assurance of sterility” mean?
The FDA lists the reason for the recall as a “lack of assurance of sterility.” That means the company cannot confirm that the affected eye drops are free from microorganisms. The FDA’s notice does not establish that every recalled bottle is contaminated.
Eye drops are placed directly in the eye, so sterility is important. The FDA has not identified the specific cause of the sterility concern in the information available for this recall.
What does Class II mean?
The FDA uses Class II for recalls involving products that may cause temporary or medically reversible health effects. The agency says the probability of serious adverse health consequences is remote.
That classification describes the FDA’s assessment of the recall risk. It does not mean the products should continue to be used. The FDA advises consumers to stop using an affected product and either dispose of it or return it to the place of purchase.
How can consumers check their eye drops?
The lot number and expiration date are printed on the product packaging. Consumers should compare those details with the affected-product list in the FDA’s recall information. The FDA list includes the specific product versions and lots covered by the recall.
People who cannot confirm whether a bottle is included can avoid using it until they check the FDA list or contact the retailer or manufacturer. Anyone who has health concerns after using eye drops should contact a health care professional, who can assess the person’s symptoms and circumstances.
