The U.S. Food and Drug Administration (FDA) has assigned its second-highest risk ranking to millions of bottles of eye drops that doctors frequently prescribe to patients after cataract surgery.
The recall, and the FDA's Class II recall, applies nationwide to 5 mL, 10 mL, and 15 mL sizes that were manufactured by Lupin Limited in India.
There have been no reports of adverse events related to the prednisolone recall so far.
“This is a standard part of the quality-control process,” UC Davis Department of Ophthalmology and Vision Science clinical professor Gary Novack said. “It shows the system to protect people who use these products is working.”
Ma, who specializes in diseases that affect the surface layers of the eye, routinely prescribes prednisolone acetate for his patients.
Ma said that the eye drops are commonly used to treat inflammatory eye conditions, such as iritis and uveitis, which are a group of diseases that cause inflammation of the iris and other surrounding structures inside the eye.
A Class I event, in contrast, is the FDA’s highest-level risk alert, and is described as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Meanwhile, a Class III event involves products that violate regulations but are unlikely to cause health problems, such as minor labeling errors.