FDA Classifies 2.53 Million Lupin Eye Drop Bottles as Class II Recall Over Foreign Substance
Updated
Updated · Boston 25 News · Jul 10
FDA Classifies 2.53 Million Lupin Eye Drop Bottles as Class II Recall Over Foreign Substance
3 articles · Updated · Boston 25 News · Jul 10
Summary
June 30 marked the FDA’s Class II designation for Lupin’s recall of 2,530,182 bottles of prednisoLONE Acetate Ophthalmic Suspension, 1%, after the products were initially recalled on June 4.
The agency said the prescription eye drops may contain a foreign substance, a risk it defines as potentially causing temporary or medically reversible health problems while making serious harm unlikely.
Lupin’s affected products were sold in 5 mL, 10 mL and 15 mL bottles, with specific recalled lot numbers and expiration dates listed in the FDA enforcement report.
The steroid eye drops are used to treat non-infectious eye allergies and inflammation, including injury from chemical and thermal burns, extending the recall’s relevance beyond post-surgery care.