FDA-Drug2025-05-14Class II
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
BRS Analytical Services, LLC
Hazard
cGMP deviations and lack of assurance of sterility.
Sold states
Nationwide in the USA
Affected count
13,872 cases (24 cartons per case)
Manufactured in
11697 Lakeside Crossing Ct, N/A, Saint Louis, MO, United States
Products
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0404-2025Don't want to check this manually?
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