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Chiesi USA, Inc. FDA Recalls
3 recalls on file across drugs, 0 of them Class I and 3 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 |
|---|
| Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Class IIIAug 19, 2026Failed Stability Specifications: Out of specification stabil |
| CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: ChClass IIJul 6, 2026Lack of Assurance of Sterility |
| CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 275Class IIMar 17, 2026Lack of Assurance of Sterility |