Product: 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.
Recall initiated: 20230908
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated