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.