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Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch...

FDA Recall #D-1317-2022 — Class II — June 29, 2022

Recall #D-1317-2022 Date: June 29, 2022 Classification: Class II Status: Terminated

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.

Recalling Firm

Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

9 boxes

Distribution

Nationwide in the USA.

Code Information

Part# 0065401105

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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