The FDA Class II eye drop recall removed more than 2.5 million bottles of Lupin Pharmaceuticals' prednisolone acetate from the market on Thursday after the products were tied to a foreign substance. The recall was nationwide and covered bottles sold in 5 mL, 10 mL and 15 mL sizes.
Lupin Pharmaceuticals recall
Lupin Pharmaceuticals initiated the recall on June 4, and the FDA posted the action on its website Thursday. The eye drops were produced by the India-based Lupin and are used to reduce inflammation after eye surgery or for allergic and other conditions.
The Class II classification places the recall in the agency's second-highest risk category, a designation used when a product may cause adverse consequences if used. For people who have the recalled bottles, the practical step is not to treat the medication as routine stock: the FDA cautioned users of the eye drops to contact their eye doctor or pharmacist in order to properly react for their own conditions.
Foreign substance question
The recall notice uses the phrase “presence of foreign substance,” but neither the FDA nor Lupin identified what that substance was or how it got into the eye drops. That leaves the product name, the bottle sizes and the recall class clear, while the contamination itself stays unspecified.
Users of the recalled prednisolone acetate should check the bottle size against the recall and act through their eye doctor or pharmacist, rather than pausing treatment without guidance.
