2.5 Million Eye Drop Bottles Recalled, FDA Says

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By Staff
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More than 2.5 million bottles of steroid eye drops have been recalled because they may be contaminated with a foreign substance, according to an enforcement report from the U.S. Food and Drug Administration (FDA). The report did not identify what the substance may be.

Lupin Pharmaceuticals issued a class 2 recall for 5 milliliter (mL), 10 mL, and 15 mL bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%. The recalled bottles have expiration dates through 3/31/2028. You can find a full list of recalled lots in the enforcement report.

A class 2 recall indicates the products in question “may cause temporary or medically reversible adverse health consequences,” or that the “probability of serious adverse health consequences is remote.”

Prednisolone eye drops are only available by prescription. The drops can relieve itchiness, redness, and swelling caused by noninfectious eye inflammation and allergies, per Mayo Clinic.

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