Chiesi Usa, Inc.: Revcovi (elapegademase-lvlr) Injection, 2.4mg/1
Revcovi Injection Recall Summary Chiesi USA is recalling Revcovi (elapegademase-lvlr) Injection 2.4mg/1.5mL in Missouri and Tennessee because testing found the protein concentration in the vial does not meet required stability standards. This is a Class III recall, meaning use of the product is unlikely to cause adverse health consequences. The recall affects patients who received this prescription medication for intramuscular injection in the affected states.
- 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.
- Classification
- Class III
- 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/712cc90f-41b3-4954-ba11-8d2c42d51d25