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.
Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the recall on Aug. 20 because of a “lack of assurance of sterility,” according to a U.S. Food and Drug Administration (FDA) enforcement report.
The FDA classified the recall as Class II on Sept. 21. The designation means use of or exposure to the affected products may cause temporary or medically reversible health consequences, while the probability of serious health consequences is considered remote.
Walgreens-branded products account for more than 500,000 units in the recall, including approximately 301,114 bottles of Walgreens Lubricant Eye Drops and 199,600 twin packs.
The broader recall also includes eye-care products distributed under the AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products and Major brands.
More than 120,000 packages of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops are affected, including individual bottles and twin packs.
Products distributed by Reliable-1 Laboratories include Sodium Chloride Hypertonicity Ophthalmic Solution 5% and Lubricating Tears.
The recall also includes 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.
The FDA says ophthalmic products pose a heightened risk because drugs applied to the eyes bypass some of the body’s natural defenses. The agency says eye drops must be sterile to reduce the risk of infection.
A representative for Walgreens did not immediately respond to FOX Business’ request for comment.