Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Onl…
Official notice from a government agency or its published feed.
Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · MO, TN
Hazard: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
View the FDA enforcement report ↗ ← All reports