D-0144-2024 Class I Ongoing
FDA drug recall D-0144-2024 was initiated by Novartis Pharmaceuticals Corporation on Nov 22, 2023 and is designated Class I. Reason for recall: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals The recall status is ongoing. Affected quantity: 6,997 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 13, 2023
- Initiation Date
- Nov 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,997 bottles
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
Distribution pattern
Nationwide within the United States
Code information
Lot #: FX001500, FX001582, Exp. 09/30/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0144-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026