United StatesRevcovi (elapegademase-lvlr) Injection 2.4 mg/1.5 mL (1.6 mg/mL) single-dose vial, NDC 10122-502-01, Lot #1221973, Exp 3/24/2027, manufactured by Chiesi USA, Inc., sold in Missouri and Tennessee (3,002 vials), is affected. The product was recalled because of an out-of-specification stability result for the protein concentration profile.
What's being recalled
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
Recalling firm: Chiesi USA, Inc., Cary, NC, United States.
How to identify it
Lot#: 1221973, Exp 3/24/2027
The hazard
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
MO, TN
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)