Recall RadarRevcovi (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
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Chiesi USA, Inc. — Cary, NC
- Severity
- Class III — low
- Reported
- September 9, 2026
- Quantity
- 3,002 vials
- Recall number
- D-0838-2026
- Status
- Ongoing
- Source
- FDA
Where it went
MO, TN
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