FDA-Drug2022-10-05Class II
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.
Novartis Pharmaceuticals Corporation
Hazard
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Sold states
Nationwide and Puerto Rico
Affected count
132,999 cartons
Manufactured in
1 Health Plz, N/A, East Hanover, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2022Don't want to check this manually?
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