Drug recall D-1317-2022

Class II Terminated reported Aug 17, 2022

Product

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.

Lots and codes

Part# 0065401105

Recall details

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Quantity
9 boxes
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
June 29, 2022
Terminated
February 13, 2024

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