FDA recall D-1317-2022

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

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.

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-08-17
Termination date: 2024-02-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2022