More than 500,000 Walgreens-branded eye-drop products are being recalled over sterility concerns as part of a broader recall involving nearly 750,000 eye-care products nationwide.
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall on August 20 due to a “lack of assurance of sterility,” according to a U.S. Food and Drug Administration (FDA) enforcement report. The agency classified the action as a Class II recall on September 21, indicating that use of the affected products may cause temporary or medically reversible health consequences, while the probability of serious adverse effects is remote.
More than 500,000 Walgreens-branded eye-drop products are being recalled. (Justin Sullivan/Getty Images, File / Getty Images)
Walgreens-branded items account for the majority of the recalled units, including approximately 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs. The broader recall also encompasses products distributed under the AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products, and Major labels.
Over 120,000 packages of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops are affected, including both individual bottles and twin packs. Products from Reliable-1 Laboratories include Sodium Chloride Hypertonicity Ophthalmic Solution 5% and Lubricating Tears. The recall further extends to 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.
Walgreens Lubricant Eye Drops are among the eye-care products recalled over concerns about sterility. (Getty Images / Getty Images)
The FDA emphasizes that ophthalmic products pose a heightened risk because drugs applied to the eyes bypass some of the body’s natural defenses, requiring sterility to mitigate the risk of infection.
Pedestrians pass in front of a Walgreens store in downtown Chicago. (Christopher Dilts/Bloomberg via Getty Images, File / Getty Images)
A representative for Walgreens did not immediately respond to a request for comment.
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