Home / Recalls / Novartis Pharmaceuticals Corporation / D-0985-2022

D-0985-2022 Class III Terminated

Recalled by Novartis Pharmaceuticals Corporation — East Hanover, NJ

Recall Details

Product Type
Drugs
Report Date
June 15, 2022
Initiation Date
May 10, 2022
Termination Date
February 28, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
279,179 vials

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023

Other recalls by Novartis Pharmaceuticals Corporation

  • D-0144-2024 Class I — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott (November 22, 2023)
  • D-1543-2022 Class II — Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx On (September 16, 2022)
  • D-0983-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Contai (May 10, 2022)
  • D-0982-2022 Class III — Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Container (May 10, 2022)
  • D-0984-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) (May 10, 2022)