FDA recalls millions of bottles of eye drops over possible 'foreign substance'
Key Points:
- The FDA has recalled over 2.5 million bottles of Lupin Pharmaceuticals' prednisolone acetate eye drops due to the presence of an unidentified foreign substance.
- The recall, classified as Class II, indicates a moderate risk of adverse effects if the eye drops are used.
- These eye drops, used to reduce inflammation after eye surgery or for allergic conditions, come in 5 mL, 10 mL, and 15 mL bottles and are manufactured by India-based Lupin.
- The FDA advises patients not to stop using the medication abruptly but to consult their eye doctor or pharmacist for appropriate guidance.
- The exact nature of the foreign substance and how it contaminated the eye drops have not been disclosed by Lupin or the FDA.