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Medicine / D-0838-2026

U.S. Food and Drug AdministrationD-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…

Class III Ohio not named in distribution Status: Ongoing

What was recalled

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

Recalling firm

Chiesi USA, Inc.

Reason for recall

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

Where it went

MO, TN

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.