Reported Dec 13, 2023 · Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM…
Novartis Pharmaceuticals Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Pharmaceuticals Corporation · 1 Health Plz · East Hanover, NJ · 07936-1016
Is this the product you have?
- SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only
- Manufactured byDELPHARM Huningue S.A.S., Huningue, France
- Distributed byNovartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
- Lot codes and dates
Lot #: FX001500FX001582Exp. 09/30/2024
- Amount recalled
- 6,997 bottles
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Using this product could cause serious injury, illness or death — stop using it now.
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