Home / Recalls / Novartis Pharmaceuticals Corporation / D-1543-2022

D-1543-2022 Class II Terminated

Recalled by Novartis Pharmaceuticals Corporation — East Hanover, NJ

Recall Details

Product Type
Drugs
Report Date
October 5, 2022
Initiation Date
September 16, 2022
Termination Date
March 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
132,999 cartons

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.

Reason for Recall

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # APCD162, Exp. 01/2023

Other recalls by Novartis Pharmaceuticals Corporation

  • D-0144-2024 Class I — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott (November 22, 2023)
  • D-0983-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Contai (May 10, 2022)
  • D-0985-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) (May 10, 2022)
  • D-0982-2022 Class III — Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Container (May 10, 2022)
  • D-0984-2022 Class III — Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) (May 10, 2022)