Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6… was recalled on August 19, 2026 in cooperation with the U.S. Food and Drug Administration because failed Stability Specifications: Out of specification stability result for the protein concentration profile..
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
Lot#: 1221973, Exp 3/24/2027
Units affected: 3,002 vials
Where it was sold: MO, TN
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Chiesi USA, Inc.
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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