Millions of bottles of eye drops have been recalled nationwide due to the potential presence of a foreign substance.
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Manufacturer Lupin Pharmaceuticals recalled 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension eye drops, according to a Food and Drug Administration enforcement report filed last month.
Thousands of products recalled
Big picture view:
The recall was initiated on June 4 but was recently classified as a Class II recall on June 30.
According to the FDA, a Class II recall means that 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 recall was initiated on June 4 but was recently classified as a Class II recall on June 30. (Credit: Getty Images)
The bottles being recalled are labeled as “prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile.” The agency is recalling 5 mL, 10 mL and 15 mL bottles.
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A full list of the recalled items with their corresponding drug codes is available on the enforcement report.
No illness history was available on the report.
Dig deeper:
According to Mayo Clinic, Prednisolone eye drops are used to treat mild to moderate non-infectious eye allergies and inflammation, including damage caused by chemical and thermal burns.
Prednisolone eye drops are also used to treat inflammation of the eyes caused by certain conditions.
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Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions.
The FDA’s enforcement report did not detail a remedy for consumers in possession of the recalled eye drops; however, the federal agency states individuals should immediately stop using any recalled products.
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FOX Local reached out to Lupin Pharmaceuticals for updated information.