D-1317-2022 Class II Terminated
FDA drug recall D-1317-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Jun 29, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products were stored outside the drug label specifications. The recall status is terminated (terminated Feb 13, 2024). Affected quantity: 9 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 17, 2022
- Initiation Date
- Jun 29, 2022
- Termination Date
- Feb 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 boxes
Product 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.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution Pattern
Nationwide in the USA.
Code Information
Part# 0065401105
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1317-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026