Reported Oct 5, 2022 · Terminated

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per…

Novartis Pharmaceuticals Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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?

  • Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton
  • Mfg byNovartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15
Lot codes and dates
    • Lot # APCD162
    • Exp. 01/2023
Amount recalled
132,999 cartons

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 11, 2024 · Data as of Sep 19, 4:19 PM UTC

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