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: Nov
Check against the official notice below — it lists the full affected range.
Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast ophthalmic solution) packaged as 60 single-use containers in 12 pouches because the medication failed impurities and degradation specifications. The recall affects approximately 1.19 million vials distributed nationwide, including multiple lot numbers with expiration dates ranging from April 2023 through November 2023.
The record does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed Impurities/Degradation Specifications.
Reason for recall: Failed Impurities/Degradation Specifications. Distribution: Nationwide within the United States Quantity: 1,187,092 vials Lot/code info: Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66, 20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22, 20S44, 20S94, Exp. Date 10/2023; 20SA6, 20SA7, 20SE0, Exp. Date 10/2023, 20TE2, 20TG5, Exp. Date 11/2023.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.