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A California-based pharmaceutical company is recalling more than 3.1 million bottles of eye drops due to concerns about sterility.<\/p>\n<\/div>\n
According to a report<\/a> by the Food and Drug Administration (FDA), K.C. Pharmaceuticals is conducting a voluntary recall of the products distributed through major national retailers, including Walgreens, Kroger, and CVS.<\/p>\n<\/div>\n The recall was initiated on March 3 and classified by the FDA on March 31. The FDA safety alert reflects both uncertainty and caution, according to experts.<\/p>\n<\/div>\n \u201cWe don\u2019t know if they really were contaminated. If they were, we don\u2019t know what type of microbe. We don\u2019t know any of that. All we know is that the manufacturer said there\u2019s an issue with sterility in these products,\u201d said Gary Novack<\/a>, PhD, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science and a consultant in ophthalmic product development.<\/p>\n<\/div>\n<\/div>\n There have been no reported injuries or illnesses related to the recalled products, which include:<\/p>\n<\/div>\n Consumers are urged to discontinue use and discard these products. <\/p>\n<\/div>\n The FDA classified the recall as a \u201c That designation does not mean there is proof of contamination, but rather that there has been a potential lapse in the manufacturing process that could compromise sterility.<\/p>\n<\/div>\n Retailers are working to address the recall and guide customers on the next steps. Healthline reached out to a number of them. <\/p>\n<\/div>\n Walgreens and Kroger did not respond by the time of publication, but a representative for CVS said, \u201cWe\u2019re committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers\u2019 needs. While the four recalled items sold by CVS were discontinued nearly a year ago, we\u2019re fully cooperating with the voluntary recall.\u201d<\/p>\n<\/div>\n The CVS representative added that customers who purchased these products may return them for a refund.<\/p>\n<\/div>\n <\/div>\n Although no illnesses have been reported due to the recall, experts say that widespread recalls do other kinds of damage.<\/p>\n<\/div>\n \u201cIt\u2019s always concerning any time we have a recall of clinical products,\u201d said Sylvia Groth<\/a>, MD, executive medical director, Department of Ophthalmology, Vanderbilt University Medical Center, and associate professor of Ophthalmology, Vanderbilt University Medical Center.<\/p>\n<\/div>\n \u201cThese events erode patient trust in over-the-counter medications. I am concerned that when I prescribe or recommend a treatment, it can be undermined by a recall,\u201d she said.<\/p>\n<\/div>\n Prescription eye drops are not part of the current recall, and anyone using these medications should feel safe and confident continuing their course.<\/p>\n<\/div>\n \u201cThey\u2019re not at risk,\u201d said Novack. \u201cWe don\u2019t want patients to stop using their prescription eye drops for glaucoma, dry eye<\/a>, or infection. It doesn\u2019t apply to them.\u201d<\/p>\n<\/div>\n Novack, who wrote about the outbreak in the journal Ophthalmology<\/a>, called the incident a \u201cperfect storm,\u201d made possible by multiple points of failure. <\/p>\n<\/div>\n He pointed to multiple points of failure, including: <\/p>\n<\/div>\n If you\u2019ve purchased one of the recalled products listed above and concerned about an potential eye infection<\/a> look for the following signs and symptoms:<\/p>\n<\/div>\n However, these symptoms are often nonspecific, meaning they can be caused by a number of issues, including allergies, Groth said.<\/p>\n<\/div>\n \u201cPatients can get very bad allergies, especially this time of year, that can mimic an infection in the eye. If it is actually an allergy-based reaction, that can be bothersome and irritating, but not something that needs any additional treatment or antibiotics,\u201d she noted.<\/p>\n<\/div>\n She added that it\u2019s important to track symptom progression, and if they aren\u2019t improving, it may be time to see a doctor.<\/p>\n<\/div>\n People who wear contacts should be especially mindful of symptoms.<\/p>\n<\/div>\n \u201cIn general, I\u2019m always more worried about my contact lens population than an otherwise healthy person using artificial tears. If you\u2019re a contact lens wearer<\/a>, you\u2019re at higher risk because you can have small, unrecognized abrasions or small ulcers that are present, and contact lenses can hold bacteria on them that other patients don\u2019t have in their eyes,\u201d Groth said.<\/p>\n<\/div>\n Here are some best practices when applying eye drops:<\/p>\n<\/div>\n\n
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