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: September 27, 2023 Initiated: September 8, 2023 #D-1174-2023
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 Corp.
- Units Affected
- 1272 bottles
- Distribution
- Nationwide in the USA
- 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 Corp.. Units affected: 1272 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 September 27, 2023. Severity: Critical. Recall number: D-1174-2023.
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