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.

Recall Number: D-0408-2025

Firm: BRS Analytical Services, LLC

Classification: Class II

Status: Ongoing

Report Date: 20250514

Initiation Date: 20250423

Termination Date:

cGMP deviations and lack of assurance of sterility.

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.