FDA-Drug2023-12-13Class I
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
Novartis Pharmaceuticals Corporation
Hazard
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Sold states
Nationwide within the United States
Affected count
6,997 bottles
Manufactured in
1 Health Plz, East Hanover, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0144-2024Don't want to check this manually?
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