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KETOTIFEN FUMARATE Recall D-1317-2022

Description: 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.

KETOTIFEN FUMARATE Recall D-1317-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1317-2022
Event ID90553
BrandZADITOR
Generic NameKETOTIFEN FUMARATE
ManufacturerKETOTIFEN FUMARATE
Original Package?1
Active SubstanceKETOTIFEN FUMARATE
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity9 boxes
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0065-4011
Recall Initiation Date20220629
Report Date20220817
Classification Date20220805
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierHBD503WORO
Drug Application NumberANDA077200
Structured Product Labeling (SPL ID)4cbfaf7f-5611-4ea6-8f21-2bee1e073cab
Structured Product Labeling (SPL Set ID)ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
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