Approximately 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension eye drops are being recalled nationwide due to a potential contamination issue. The U.S. Food and Drug Administration (FDA) flagged 2,530,182 bottles of the prescription medication manufactured by Lupin Pharmaceuticals Inc. at a facility in Pithampur, India.
The recall covers all sizes of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, including 5 mL, 10 mL, and 15 mL bottles. The product is commonly used to treat eye inflammation, allergies, redness, itching, and swelling caused by infections, or damage from chemical and thermal burns.
Lupin Pharmaceuticals initiated the voluntary recall, a process where manufacturers take responsibility for public health by addressing identified issues. The recall was first initiated on June 4 and was classified as a Class II recall on June 30. This classification indicates a moderate risk, meaning the product could cause temporary or medically reversible health problems.
The affected bottles are labeled as “prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only.” The National Drug Codes for the recalled products are NDC 70748-332-02 (5 mL), NDC 70748-332-03 (10 mL), and NDC 70748-332-04 (15 mL). The manufacturer is Lupin Limited, Pithampur (M.P) 454 775, INDIA, and the recall number is D-0655-2026.
The FDA has advised individuals to stop using any recalled product immediately. The agency has not disclosed a specific remedy for consumers who may have used the affected eye drops.