Neoral soft gelatin capsules Modified recalled over manufacturing violations
- Recall date
- September 16, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Novartis Pharmaceuticals Corporation recalls Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton…
- Recall number
- D-1543-2022
- FDA classification
- Class II
- Brand / firm
- Novartis Pharmaceuticals Corporation
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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