Recall alert: 2.5M bottles of eye drops recalled for foreign substance
Key Points:
- The FDA has announced a Class II recall of millions of bottles of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, due to potential contamination with a foreign substance.
- These prescription eye drops, made by Lupin Pharmaceuticals, are used to treat non-infectious eye allergies and inflammation, including damage from chemical and thermal burns.
- The recall affects three bottle sizes: 5 mL, 10 mL, and 15 mL, with specific lot numbers and expiration dates listed by the FDA.
- The recall was initially issued on June 4, with the FDA officially classifying it as Class II on June 30, indicating a risk of temporary or reversible health effects.