Novartis Pharmaceuticals Corporation recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM H
Recalled December 13, 2023 · FDA recall D-0144-2024 · Novartis Pharmaceuticals
Hazard
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals · FDA Class I
Units
6,997 bottles
Sold at
Nationwide within the United States
Description
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
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
Manufacturer(s)
Novartis Pharmaceuticals Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →