FDA Recalls Over 3 Million Eye Drop Bottles Due to Sterility Concerns
核心洞察
K.C. Pharmaceuticals (搜索) voluntarily recalled 3,111,072 bottles of over-the-counter eye drops in early March after the FDA cited a "lack of assurance of sterility."
The recalled products include multiple formulations sold under various brand names at major retailers including CVS, Walgreens, Rite Aid, Kroger, and other pharmacy chains.
The FDA classified this as a Class II recall, indicating the products may cause temporary or medically reversible adverse health consequences.
K.C. Pharmaceuticals (搜索) of Pomona, California, has issued a voluntary recall of over 3 million bottles of over-the-counter eye drop products after the Food and Drug Administration cited a "lack of assurance of sterility." The recall, which began in early March, affects 3,111,072 bottles of various eye drop formulations sold under multiple brand names at major retail chains across the United States.
Affected Products and Retailers
The recall encompasses six different eye drop formulations sold under numerous brand names at major retailers including CVS, Walgreens, Rite Aid, Kroger, and other pharmacy chains. The affected products include:
Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%) sold under brands including Best Choice, CareOne, Discount Drug Mart, Equaline, Good Sense, H.E.B A.C., Meijer, QC-Quality Choice, TopCare Health, and Walgreens.
Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 (搜索) 1% and tetrahydrozoline HCl 0.05%) available under CVS Health, DG Health, Discount Drug Mart, Fast Acting, Foster & Thrive, Good Sense, Kroger, QC-Quality Choice, TopCare Health, and Walgreens brands.
Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 (搜索) 1%) sold under DG Health, Discount Drug Mart, Exchange Select, Foster & Thrive, Geri Care, Good Neighbor Pharmacy, H-E-B, Harris Teeter, Leader, Meijer, Rite Aid, and TopCare Health.
Additional recalled formulations include Ultra Lubricating Eye Drops, Sterile Eye Drops Original Formula, Sterile Eye Drops Redness Lubricant, Sterile Eye Drops Soothing Tears, and Artificial Tears Sterile Lubricant Eye Drops, each sold under various retail brand names.
Safety Classification and Consumer Guidance
The FDA has classified this action as a Class II recall, which applies to products that can cause "temporary or medically reversible" health problems. According to FDA guidelines, people can continue using their medication during a Class II recall unless stated otherwise by the company.
No injuries associated with the recalled eye drops have been reported to date. However, consumers who have purchased these products are advised to stop using them and contact their place of purchase to confirm recalled lot codes and expiration dates to request a refund.
Company Response and Investigation
The specific trigger for the recall remains unclear, as K.C. Pharmaceuticals (搜索) did not immediately respond to requests for comment. The company manufactures these products for numerous brands sold under various names including "Dry Eye Relief Eye Drops," "Sterile Eye Drops," and "Artificial Tears Sterile Lubricant Eye Drops."
Consumers experiencing health concerns after using the recalled eye drops are advised to contact a healthcare provider immediately. For questions about the recall, the FDA can be reached at 1-888-INFO-FDA (1-888-463-6332).