Recall D-0838-2026
Recalling firm
Chiesi USA, Inc., NC
Product
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
Reason for recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.