WASHINGTON, DC — Federal regulators have recalled more than 500,000 eye drop products after raising sterility concerns tied to a lack of assurance that the items were safe to use. The U.S. Food and Drug Administration said Sterling Pharmaceutical Services LLC initiated the recall on Aug. 20, affecting products sold under several brand names, including Walgreens.
The agency said the action is a Class II recall, a category used when exposure to a product may cause temporary or medically reversible health problems, while the chance of serious harm is considered remote. In total, the recall covers nine products and nearly 750,000 units.
Walgreens products make up a large share of the recalled eye drops
Walgreens products account for a significant portion of the recalled items. More than 300,000 bottles of Walgreens Lubricant Eye Drops, 0.5 fluid ounces, were included in the action, along with 199,600 twin packs of the same product sold and distributed by Walgreens.
The recall also extends to other store and pharmacy brands. Those products include AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Cameron Pharmaceuticals’ Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops, TRP The Relief Products Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment.
Other recalled products include AvKare, Cameron, TRP and Major brands
Among the other products listed by the FDA are more than 12,800 packs of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, 0.5 fluid ounces, plus 107,377 packs of the two-count twin packs distributed by AvKare. The recall also includes 19,284 bottles of Cameron Pharmaceuticals’ lubricant eye drops.
In addition, 14,538 bottles of TRP The Relief Products Gentle Eyes Lubricant Eye Drops were recalled, along with 34,368 tubes of Major LubriFresh P.M. Nighttime Ointment. The FDA said consumers can check its website for the full list of affected products.
FDA says exposure could cause temporary or reversible health effects
The FDA’s Class II designation signals that the products may lead to temporary or medically reversible adverse health consequences if used or exposed. The agency said the probability of serious adverse health effects is remote, but it still urged consumers to take the recall seriously.
Because the concern involves sterility, the products are being treated as potentially unsafe even though the agency has not described a widespread injury pattern. The recall reflects a preventive move aimed at removing possibly contaminated eye drops from circulation before more people use them.
Consumers told to stop using affected eye drops and contact doctors
People who have any of the recalled products should stop using them immediately, the FDA said. Consumers are also being advised to speak with their doctors about next steps, especially if they have already used the products and have concerns about irritation or infection.
Eye drops are applied directly to the eye, so sterility is a critical safety issue. The agency’s warning is designed to reduce the chance that users continue applying products that may not meet sterility standards.
Recall follows earlier eye drop safety actions this year
The latest action comes after other eye drop recalls earlier this year. More than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief were recalled in August. Before that, 2.5 million bottles of Lupin Pharmaceuticals prescription eye drops were recalled in the prior month because of contamination concerns.
Those earlier actions show that eye drop safety has remained under close scrutiny in recent months. For consumers, the latest recall is another reminder to check product names, package sizes and lot details against the FDA list before using any lubricating or prescription eye drops already at home.
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