Home / Recalls / Novartis Pharmaceuticals Corporation / D-0144-2024

D-0144-2024 Class I Ongoing

Recalled by Novartis Pharmaceuticals Corporation — East Hanover, NJ

Recall Details

Product Type
Drugs
Report Date
December 13, 2023
Initiation Date
November 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,997 bottles

Product Description

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22

Reason for Recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: FX001500, FX001582, Exp. 09/30/2024

Other recalls by Novartis Pharmaceuticals Corporation

  • 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-0985-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) (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)