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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1317-2022 |
| Event ID | 90553 |
| Brand | ZADITOR |
| Generic Name | KETOTIFEN FUMARATE |
| Manufacturer | KETOTIFEN FUMARATE |
| Original Package? | 1 |
| Active Substance | KETOTIFEN FUMARATE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 9 boxes |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0065-4011 |
| Recall Initiation Date | 20220629 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | HBD503WORO |
| Drug Application Number | ANDA077200 |
| 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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