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, Inc., Cary, NC 27518, NDC 10122-502-01

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — drug enforcement reference
Source observed: 9/9/2026, 12:00:00 AM UTC
Source updated: 9/9/2026, 12:00:00 AM UTC
Location: Cary, NC, US
hazard: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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
distribution: MO, TN
manufacturer: Chiesi USA, Inc.
recall number: D-0838-2026
source status: Ongoing
classification: Class III
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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