Chiesi Usa, Inc.: Revcovi (elapegademase-lvlr) Injection, 2.4mg/1
Chiesi USA is recalling Revcovi (elapegademase-lvlr) Injection 2.4mg/1.5mL vials distributed in Missouri and Tennessee because testing found the protein concentration in the medication did not meet stability specifications. This recall affects patients who received this injectable medication, which is used to treat adenosine deaminase deficiency.
- Recalling firm
- 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.
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-19
- Status
- Ongoing
- Areas affected
- MO, TN
- Distribution
- MO, TN
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/51731e88-c65a-4c99-bc46-b1a88361e037