FDAFDA · Food and drugs·Recall number D-1543-2022
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Published October 5, 2022 · Recall initiated: September 16, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NEORAL
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # APCD162, Exp. 01/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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