Several eye drop brands have been pulled from shelves nationwide over sterility concerns, according to an enforcement report from the U.S. Food and Drug Administration.
K.C. Pharmaceuticals, Inc. initiated a voluntary recall on March 3, affecting more than three million eye drop products due to concerns that they may not be sterile.
The FDA classified the recall as a Class II safety risk on March 31. A Class II classification means exposure to the product may cause temporary or medically reversible adverse health consequences.
Using eye drops that are not sterile puts consumers at risk of eye infections that may result in vision loss. Consumers who have any symptoms of an eye infection after using the recalled products should contact their healthcare provider.
The products can be identified by their UPC codes, lot numbers code information and expiration dates printed on the bottom of the bottles. View the FDA enforcement report for the full list.
The following eye drop products are included in the recall:
182,424 bottles of Sterile Eye Drops A.C.
303,216 bottles of Advanced Relief Eye Drops
1,023,096 bottles of Dry Eye Relief Eye Drops
245,184 bottles of Ultra Lubricating Eye Drops
378,144 bottles of Sterile Eye Drops (Original Formula)
315,144 bottles of Sterile Eye Drops Redness Lubricant
74,016 bottles of Sterile Eye Drops Soothing Tears
589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops
The recalled products were sold in 0.5-fluid-ounce bottles under the following brand names and through these distributors:
P High Performance (Publix)
Lil’ Drug Store Products
While the FDA has not yet issued specific guidance for this recall, the agency typically advises consumers to stop using recalled products immediately and dispose of them properly.
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