⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Chiesi USA, Inc.: 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,

DrugsSource: FDA (drug) · Date: 2026-09-09

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Chiesi USA, Inc.
Product
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
Reason / hazard
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Classification
Class III
Status
Ongoing
Distribution / sold at
MO, TN
Recall initiated
2026-08-19
Code info
Lot#: 1221973, Exp 3/24/2027
Product quantity
3,002 vials
Voluntary mandated
Voluntary: Firm initiated
City
Cary
State
NC
Country
United States
Event id
99705
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