Class II

Drug Recall: 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.

BRS Analytical Services, LLC · April 23, 2025

Reason for Recall

cGMP deviations and lack of assurance of sterility.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

14,333 cases (24 cartons per case)

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0408-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

BRS Analytical Services, LLC Drug Recall: 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. | SafeCheck