The US FDA issued alerts recently regarding the recalls of five ocular lubricant products and one generic glaucoma medication.

BRS Analytical Services, a contract testing laboratory based in St. Louis, Missouri, initiated a voluntary recall on April 23 of nearly 76 thousand of cases of five dry eye products distributed in the US by AvKare, of Pulaski, Tennessee.

An FDA audit had revealed deviations from the agency’s current good manufacturing practice regulations and a lack of assurance of sterility.

The recalled products, which were shipped from May 26, 2023, to April 21, 2025, are:

—13,872 cases of artificial tears ophthalmic solution (NDC 50268-043-15)

—1,610 cases of carboxymethylcellulose sodium ophthalmic gel 1% (NDC 50268-066-15)

—32,876 cases of carboxymethylcellulose sodium ophthalmic solution (NDC 50268-068-15)

—13,104 cases of lubricant eye drops solution (NDC 50268-126-15)

—14,333 cases of polyvinyl alcohol ophthalmic solution (NDC 50268-678-15)

AvKare said the health hazards are not currently known, but the FDA designated the recalls as Class II, indicating potential “temporary or medically reversible adverse health consequences.”

A recall notice from AvKare says consumers should immediately stop using the products. Consumers can complete AvKare’s recall form and return it to the company by fax or email, then ship the products back to AvKare.

Glaucoma Drop Bottle Issues

Another FDA Class II recall notice involves 10 mL bottles of generic timolol maleate 0.5% eye drops for glaucoma, manufactured by India’s FDC Limited and distributed in the US by Rising Pharmaceuticals, of New Jersey.

The notice said FDC recalled 60,428 bottles with lot number 083I098 and an expiration date of Aug. 31, 2025, because the containers are defective.

The spike of the cap was lodged in the nozzle of the product bottle, and the medication couldn’t be dispensed.

More News

Want to Read Locked Articles?

Already Have an Account?

Register A Corporate Account

Topics of Interest

Products of Interest