SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manu...
FDA Recall #D-0144-2024 — Class I — November 22, 2023
Product Description
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
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Recalling Firm
Novartis Pharmaceuticals Corporation — East Hanover, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
6,997 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: FX001500, FX001582, Exp. 09/30/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated