Lupin recall covers 5 mL, 10 mL, 15 mL bottles of steroid eye drops
The U.S. Food and Drug Administration on Thursday announced a nationwide recall of more than 2.5 million bottles of prednisolone acetate eye drops produced by Lupin Pharmaceuticals because they may contain a foreign substance, according to a recall notice posted on the agency’s website.
Lupin initiated the voluntary recall on June 4, but the FDA published the enforcement report on July 9. Neither the company nor the agency has identified the foreign substance or determined how it entered the product, the recall notice stated.
The FDA classified the action as a class II recall, the second-highest risk level, meaning the product could cause temporary or medically reversible adverse health consequences. The recall affects bottles in 5 mL, 10 mL and 15 mL quantities of the prednisolone acetate ophthalmic suspension.
Lupin, based in India, specializes in manufacturing generic pharmaceutical medications. The recalled eye drops are commonly prescribed to reduce inflammation following eye surgery and for allergic or inflammatory conditions.
The FDA cautioned against discontinuing the medication without medical guidance. The agency recommended that patients using the drops contact their eye doctor or pharmacist to determine the appropriate course of action for their condition.