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.
Recall Number: D-1543-2022
Firm: Novartis Pharmaceuticals Corporation
Classification: Class II
Status: Terminated
Report Date: 20221005
Initiation Date: 20220916
Termination Date: 20240311
Reason for Recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Product Description
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.