FDA recall D-1543-2022

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 for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2022-09-16

Report date

2022-10-05

Termination date

2024-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2022