FDAFDA · Food and drugs·Recall number D-0985-2022
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
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
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Distributor
- Nationwide within the United States
- Lot
- Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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