Millions of bottles of a commonly prescribed eye drop used to treat eye inflammation and allergic conditions are being recalled nationwide, according to the U.S. Food and Drug Administration.
Lupin Pharmaceuticals Inc. has voluntarily recalled more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension after the potential presence of a foreign substance was identified, the FDA said in a recall notice.
The prescription medication is a corticosteroid eye drop used to reduce redness, itching, and swelling caused by eye infections and other inflammatory conditions.
According to the Mayo Clinic, prednisolone ophthalmic is available only by prescription and is commonly used to help manage inflammation in the eye. Patients who use the recalled product should check the lot information and contact their healthcare provider or pharmacist if they have questions about their medication.
(Recall information)
Product description: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only
5 mL (NDC 70748-332-02)
10 mL (NDC 70748-332-03)
15 mL (70748-332-04)
Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Product Quantity: 2,530,182 bottles
Recall Number: D-0655-2026
The recall, which was initiated early last month but classified as a Class II recall last week, spans dozens of individual lot codes and separate bottles.
