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

Recall date

September 8, 2023

Source

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

Recall number

D-1174-2023

FDA classification

Class I

Brand / firm

Novartis Pharmaceuticals Corp.

Sold / distributed

Nationwide in the USA

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.