Class II Recall

Novartis Pharmaceuticals Corporation

Product
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.
Reason
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Classification
Class II
Status
Terminated
Lot
Lot # APCD162, Exp. 01/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.