Novartis Pharmaceuticals Corporation recalls Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton,
Recalled October 5, 2022 · FDA recall D-1543-2022 · Novartis Pharmaceuticals
Hazard
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. · FDA Class II
Units
132,999 cartons
Sold at
Nationwide and Puerto Rico
Description
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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.
Manufacturer(s)
Novartis Pharmaceuticals Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →