Drug product
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
D-0144-2024
Product summary
- Event
- Event 93464
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 6,997 bottles
- Official record key
drug-enforcement:D-0144-2024
Official wording
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Code information: Lot #: FX001500, FX001582, Exp. 09/30/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals