Chiesi USA, Inc. Provisional
FDA Flags (3)
Class III RecallSep 2026
Chiesi USA, Inc.
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only,
Classification: Class III
Class II RecallJul 2026
Chiesi USA, Inc.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Ch
Classification: Class II
Class II RecallApr 2026
Chiesi USA, Inc.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 275
Classification: Class II