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Revcovi (elapegademase-lvlr) Injection
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Revcovi (elapegademase-lvlr) Injection

Chiesi USA recalls Revcovi ( elapegademase-lvlr) Injection over failed stability specifications.

What to do

Consumers with this product should stop using it and contact their healthcare provider or Chiesi USA for guidance on returning the product or obtaining a replacement.

Recalled
Listed
Updated
Agency
FDA
Firm
Chiesi USA, Inc.
Recall ID
99705
Status
ONGOING

Recall at a glance

Quantity recalled
3,002 vials

Why it was recalled

Chiesi USA is recalling Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, due to an out-of-specification stability result for the protein concentration profile.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Revcovi (elapegademase-lvlr) Injection

Lot code
1221973, 2027
Strength
2.4 mg
NDC / UPC
NDC 10122-502-01

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Failed Specifications recalls

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All recalls from Chiesi USA, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-30 · primary source: U.S. Food and Drug Administration