FDA-Drug2022-06-15Class III
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
Novartis Pharmaceuticals Corporation
Hazard
Failed Impurities/Degradation Specifications.
Sold states
Nationwide within the United States
Affected count
1,187,092 vials
Manufactured in
1 Health Plz, East Hanover, NJ, United States
Products
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0982-2022Don't want to check this manually?
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