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