Novartis Pharmaceuticals Corporation recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM…

Recall date

November 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0144-2024

FDA classification

Class I

Brand / firm

Novartis Pharmaceuticals Corporation

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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