Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Systane Zaditor Recalled by Mckesson Medical-Surgical Inc. Corporate Office Due to CGMP Deviations: products were stored outside the drug...

Date: June 29, 2022
Company: Mckesson Medical-Surgical Inc. Corporate Office
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mckesson Medical-Surgical Inc. Corporate Office directly.

Affected Products

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.

Quantity: 9 boxes

Why Was This Recalled?

CGMP Deviations: products were stored outside the drug label specifications.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mckesson Medical-Surgical Inc. Corporate Office

Mckesson Medical-Surgical Inc. Corporate Office has 276 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report