FDAFDA · Food and drugs·Recall number D-0982-2022
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.
Published June 15, 2022 · Recall initiated: May 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- XIIDRA
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Distributor
- Nationwide within the United States
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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