FDAFDA · Food and drugs·Recall number D-0838-2026
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
Published September 9, 2026 · Recall initiated: August 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- REVCOVI
- Manufacturer
- Chiesi USA, Inc.
- Distributor
- MO, TN
- Lot
- Lot#: 1221973, Exp 3/24/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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