FDAFDA · Food and drugs·Recall number D-0984-2022
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), 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) 20DJ3, Exp. Date 03/2023.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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