Official recall notice
FDA DrugClass IIINotable
FDA Recall: Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intr
- Recall date
- 2026-09-09
- Brand
- Chiesi USA, Inc.
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Product description
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Affected products
Lot#: 1221973, Exp 3/24/2027