Novartis Pharmaceuticals Corporation: Drug Recall
Recall #D-0144-2024 · 11/22/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0144-2024
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Status
- Ongoing
- Date Initiated
- 11/22/2023
- Location
- East Hanover, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,997 bottles
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Novartis Pharmaceuticals Corporation
- Class II: Risk 09/16/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.