Class III Recall

Chiesi USA, Inc.

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
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Classification
Class III
Status
Ongoing
Lot
Lot#: 1221973, Exp 3/24/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.