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-1174-2023
Product summary
- Event
- Event 92975
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1272 bottles
- Official record key
drug-enforcement:D-1174-2023
Official wording
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Code information: FX001691, Exp. 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.