FDAFDA · Food and drugs·Recall number 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 Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
Published December 13, 2023 · Recall initiated: November 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Distributor
- Nationwide within the United States
- Lot
- Lot #: FX001500, FX001582, Exp. 09/30/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.