FDA Drug Class I — Most Serious

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

Hazard

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

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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 Corpo
Brand
Novartis Pharmaceuticals Corporation
UPC
Lot #: FX001500, FX001582, Exp. 09/30/2024

Units Affected

6,997 bottles

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