FDA-Drug2022-08-17Class II
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.
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
CGMP Deviations: products were stored outside the drug label specifications.
Sold states
Nationwide in the USA.
Affected count
9 boxes
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2022Don't want to check this manually?
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