FDAFDA · Food and drugs·Recall number D-1174-2023
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 September 27, 2023 · Recall initiated: September 8, 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 Corp.
- Distributor
- Nationwide in the USA
- Lot
- FX001691, Exp. 12/31/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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