Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

Recall Number: D-1317-2022

Firm: Mckesson Medical-Surgical Inc. Corporate Office

Classification: Class II

Status: Terminated

Report Date: 20220817

Initiation Date: 20220629

Termination Date: 20240213

CGMP Deviations: products were stored outside the drug label specifications.

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.