Lupin Pharmaceuticals is recalling more than 2.5 million bottles of prescription eye drops nationwide over the potential presence of a foreign substance, according to a Food and Drug Administration enforcement report.
The recall covers 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, a steroid medication used to treat eye inflammation. The report did not specify what type of foreign substance may be present in the product.
The company, based in India, initiated the action on June 4, and the FDA classified it as a Class II recall on June 30. Under FDA guidelines, a Class II designation means use of the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The affected products are labeled “prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile.” The recall applies to 5 mL, 10 mL, and 15 mL bottles. A complete list of the recalled products and their drug codes is included in the FDA enforcement report.
No illnesses linked to the recalled bottles have been reported, according to the enforcement report.
According to the Mayo Clinic, prednisolone eye drops are prescribed to “treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns. The medication is also used to “relieve redness, itching, and swelling” tied to eye infections and certain other conditions.
The FDA’s enforcement report did not outline a specific remedy for consumers who have the recalled product. The agency advises individuals to immediately stop using any recalled products.
Provided by Dallas Express
