Sterling Pharmaceutical Services LLC launched a recall on Aug.
20 covering nearly 750,000 eye-care products, including more than 500,000 Walgreens-branded items, due to potential sterility issues.
The U. S.
Food and Drug Administration classified the action as a Class II recall on Sept. 21, according to an FDA enforcement report.
That classification means exposure to the affected eye drops could cause temporary or medically reversible health problems, while serious health risks remain unlikely.
Walgreens and Other Brands Affected
Walgreens products account for more than 500,000 units of the total affected inventory.
This includes roughly 301,114 individual bottles of Walgreens Lubricant Eye Drops and 199,600 twin-pack units.
The nationwide recall also covers ophthalmic products from AvKare, Reliable-1 Laboratories, Cameron Pharmaceuticals, TRP The Relief Products, and Major.
Affected stock includes over 120,000 packages of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops in single bottles and twin packs.
Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5% and Lubricating Tears are also part of the recall.
Additional items include 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 notes that ophthalmic medications require complete sterility because drugs applied directly to the eyes bypass several natural body defenses, raising the risk of infection.
A representative for Walgreens did not immediately respond to requests for comment regarding the recall.
