Class IIOngoing

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall

FDA recall D-0406-2025 · initiated Apr 23, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP deviations and lack of assurance of sterility.

Details

Product: 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.
Recalling company: BRS Analytical Services, LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Apr 23, 2025
FDA report date: May 14, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0406-2025 ↗

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