Class III · Low risk
Klarity-C Drops
Subpotent Drug
SANDIMMUNE Oral Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What 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
Affected NDC
0078-0110-22
Compare with the code on your package — it is the most precise check available.
Drug: Cyclosporine
- Recalling firm
- Novartis Pharmaceuticals Corporation
- NDC code
- 0078-0110-22
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0144-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Cyclosporine recalls
See all
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class II · Moderate risk
Cyclosporine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Novartis Pharmaceuticals Corporation
All 2023 recalls
Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
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