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 #: FX001500
    • FX001582
    • Exp. 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.