FDASeptember 8, 2023drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

novartis pharmaceuticalsnovartis

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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