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Novartis Pharmaceuticals Corporation FDA Recalls
7 recalls on file across drugs, 1 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 2783Class IIAug 4, 2026Failed Dissolution Specifications |
| SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM HClass INov 22, 2023Crystallization: bottles of Sandimmune Oral Solution were d |
| Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton,Class IISep 16, 2022CGMP deviations: Out of specification results obtained durin |
| Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers Class IIIMay 10, 2022Failed Impurities/Degradation Specifications. |
| Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containeClass IIIMay 10, 2022Failed Impurities/Degradation Specifications. |
| Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each viaClass IIIMay 10, 2022Failed Impurities/Degradation Specifications. |
| Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each viaClass IIIMay 10, 2022Failed Impurities/Degradation Specifications. |