FDA · Enforcement report ·
FDA recalls Rohto Cooling Eye Drops Dry Aid
The FDA has recalled Rohto Cooling Eye Drops Dry Aid because there is a lack of assurance of sterility for products distributed nationwide in the U.S.
The Food and Drug Administration (FDA) has recalled Rohto Cooling Eye Drops Dry Aid, a sterile eye product distributed nationwide in the United States. The recall reason is a lack of assurance of sterility.
Sterile means free from germs. The FDA alert says the product may not have the expected sterility assurance.
This recall is listed as a Class II recall by the FDA. Class II indicates a recall that may cause temporary or medically reversible harm.
What we explain about this
CryoglobulinemiaCryoglobulinemia is the presence of abnormal blood proteins that can clump in the cold and sometimes inflame or block blood vessels.Dry eye syndromeDry eye syndrome is a condition in which unstable or insufficient tears leave the eyes irritated and uncomfortable.Eye retraction syndromeEye retraction syndrome is a lifelong condition that limits sideways eye movement and pulls the eye backward during certain movements.