Carboxymethylcellulose Sodium Ophthalmic Solution 0 recalled over sterility concerns

Recall date

April 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BRS Analytical Services, LLC recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating E…

Recall number

D-0406-2025

FDA classification

Class II

Brand / firm

BRS Analytical Services, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

cGMP deviations and lack of assurance of sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.