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Nearly 750,000 bottles of eye drops recalled over sterility concerns

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The products were sold under multiple brand names, including Walgreens

(Manuel Balce Ceneta, Copyright 2020 The Associated Press. All rights reserved.)

Hundreds of thousands of eye products have been recalled over concerns that they may not be sterile, according to the U.S. Food and Drug Administration.

Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, began the recall on Aug. 20 due to a “lack of assurance of sterility.” The recall involves nine eye care products sold under multiple brand names, including Walgreens.

On Sept. 21, the U.S. Food and Drug Administration designated the recall as a Class II, meaning the use of or exposure to this product could cause temporary or medically reversible adverse health consequences.

The affected products include lubricant eye drops, a hypertonicity eye solution, and a nighttime eye ointment:

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 fluid ounces: 12,864 packs

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 fluid ounces (15 mL) bottles: 11,083 bottles

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 fluid ounces (15 mL) bottles: 301,114 bottles

Walgreens Lubricant Eye Drops, two-count Twin Pack: 199,600 packs

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 fluid ounces (15 mL) bottles: 47,616 bottles

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 fluid ounces (15 mL) bottles: 14,538 bottles

Major LubriFresh P.M. Nighttime Ointment, 0.125 oz. (3.5 g) tubes: 34,368 tubes

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 fluid ounces (15 mL) bottles: 19,284 bottles

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, two-count twin pack: 107,377 packs

Consumers who believe they may have products involved in this recall are urged to immediately stop using the eye product and speak with their doctor. For more information on the specific lot numbers and expiration dates for the affected products, click here.

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