FDA-Drug2025-05-14Class II
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Hazard
cGMP deviations and lack of assurance of sterility.
Sold states
Nationwide in the USA
Affected count
13,104 cases (24 cartons per case)
Manufactured in
11697 Lakeside Crossing Ct, N/A, Saint Louis, MO, United States
Products
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2025Don't want to check this manually?
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