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
Reported: December 13, 2023 Initiated: November 22, 2023 #D-0144-2024
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
Details
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Units Affected
- 6,997 bottles
- Distribution
- Nationwide within the United States
- Location
- East Hanover, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novartis Pharmaceuticals Corporation. Units affected: 6,997 bottles.
Why was this product recalled? ▼
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 13, 2023. Severity: Critical. Recall number: D-0144-2024.
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