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FDARecalled Dec 13, 2023 · #D-0144-2024

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 Co...

Hazard

Class I — serious health risk

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Description

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals Classification: Class I Distribution: Nationwide within the United States

Product details

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
Type
Drugs
Manufacturer
Novartis Pharmaceuticals Corporation
Model numbers
FX001500
UPCs