foundmatterdb

Field reports on stuff that let you down

FDA recallMedicationsClass III· Chiesi USA, Inc.

Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Onl…

Official notice from a government agency or its published feed.

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: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · MO, TN

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

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