Carboxymethylcellulose Sodium Ophthalmic Gel 1% 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 Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soo…
- Recall number
- D-0405-2025
- 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 Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
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