Product: 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.
Reason for recall: CGMP Deviations: products were stored outside the drug label specifications.
Recall initiated: 20220629
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated