Polyvinyl Alcohol Ophthalmic Solution 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 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bo…
- Recall number
- D-0408-2025
- 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
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
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