Drug recall D-0838-2026

Class III Ongoing reported Sep 9, 2026

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 for recall

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Lots and codes

Lot#: 1221973, Exp 3/24/2027

Recall details

Recalling firm
Chiesi USA, Inc., Cary, NC
Quantity
3,002 vials
Distribution
MO, TN
Type
Voluntary: Firm initiated
Recall initiated
August 19, 2026

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