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 # APCD162Exp. 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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