FDAFDA · Food and drugs·Recall number D-1317-2022
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.
Published August 17, 2022 · Recall initiated: June 29, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products were stored outside the drug label specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZADITOR
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- Nationwide in the USA.
- UPC
- 0300654011057
- Lot
- Part# 0065401105
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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