FDA-Drug2025-05-14Class II
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.
BRS Analytical Services, LLC
Hazard
cGMP deviations and lack of assurance of sterility.
Sold states
Nationwide in the USA
Affected count
14,333 cases (24 cartons per case)
Manufactured in
11697 Lakeside Crossing Ct, N/A, Saint Louis, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2025Don't want to check this manually?
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