Xiidra recall: Impurity Out of Spec
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.
Why was Xiidra recalled?
Failed Impurities/Degradation Specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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.
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Quantity
- 1,187,092 vials
- Distribution
- Nationwide within the United States
- Recall date
- June 15, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)