Product: 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.
Reason for recall: cGMP deviations and lack of assurance of sterility.
Recall initiated: 20250423
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated