More than 2.5 million bottles of a prescription eye medication used to treat eye inflammation and allergies have been recalled in the after the US Food and Drug Administration (FDA) flagged the possible presence of a foreign substance in the product, reported.
According to the recall notice, Lupin Pharmaceuticals Inc. is voluntarily recalling 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, a prescription-only medication commonly prescribed to reduce redness, itching and swelling caused by eye infections and other conditions.
Why Were The Eye Drops Recalled?
The FDA said the recall was initiated because of the potential presence of a foreign substance in the eye drops.
The product involved in the recall is:
Product: Prednisolone Acetate Ophthalmic Suspension, USP, 1% (Rx only)
- 5 mL: NDC 70748-332-02
- 10 mL: NDC 70748-332-03
- 15 mL: NDC 70748-332-04
The medication was manufactured by Lupin Limited, Pithampur, Madhya Pradesh, India.
What Is Prednisolone Acetate Used For?
According to the Mayo Clinic, prednisolone is a steroid medicine prescribed to relieve redness, itching and swelling caused by eye infections and several other eye conditions.
The Mayo Clinic describes the medicine as follows:
“Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions. This medicine is available only with your doctor’s prescription.”
Because it is a prescription medicine, patients are advised not to discontinue or replace the medication without consulting their healthcare provider.
FDA Classifies It As A Class II Recall
The recall was initiated early last month and was later classified by the FDA as a Class II recall last week.
According to the FDA, a Class II recall applies to products where the use of or exposure to the product “may cause temporary or medically reversible adverse health consequences,” or where the probability of serious health consequences is considered remote.
The recall covers multiple lot numbers across the affected bottle sizes. Patients who have been prescribed the medication are advised to check whether their prescription is among the recalled lots.
Company Yet To Comment
According to the report, Lupin Pharmaceuticals Inc. had not immediately responded to requests for comment regarding the recall.
The FDA’s recall notice advises consumers and healthcare providers to review the affected lot information before using the product. Those who believe they may have a recalled bottle should consult their pharmacist or prescribing doctor for guidance.
The recall comes as regulatory agencies continue to monitor the quality and safety of pharmaceutical products, particularly medicines intended for sensitive areas such as the eyes.
