Chiesi USA, Inc.
NDC labeler code: 10122
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Lomitapide mesylateJuxtapid · 5 products
- DeferiproneFerriprox · 3 products
- Pegunigalsidase alfaElfabrio · 2 products
- ClevipidineCleviprex · 2 products
- Birch triterpenesFilsuvez · 1 product
- Velmanase alfa-tycvLamzede · 1 product
- Poractant alfaCurosurf · 1 product
- CangrelorKengreal · 1 product
- ZileutonZyflo · 1 product
- MetreleptinMyalept · 1 product
- OctreotideMycapssa · 1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- Elapegademase-lvlrRevcovi · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 18, 2023 | NDA215064 | Birch triterpenes FILSUVEZ | Chiesi |
| May 9, 2023 | BLA761161 | Pegunigalsidase alfa ELFABRIO | Chiesi Farmaceutici Spa |
| February 16, 2023 | BLA761278 | Velmanase alfa-tycv LAMZEDE | Chiesi Farmaceutici Spa |
| June 26, 2020 | NDA208232 | Octreotide MYCAPSSA | Chiesi |
| May 19, 2020 | NDA212269 | Deferiprone FERRIPROX | Chiesi |
| October 5, 2018 | BLA761092 | Elapegademase-lvlr REVCOVI | Chiesi USA Inc |
| September 9, 2015 | NDA208030 | Deferiprone FERRIPROX | Chiesi |
| June 22, 2015 | NDA204958 | Cangrelor KENGREAL | Chiesi |
| February 24, 2014 | BLA125390 | Metreleptin MYALEPT | Chiesi Farmaceutici Spa |
| December 21, 2012 | NDA203858 | Lomitapide mesylate JUXTAPID | Chiesi |
| October 12, 2012 | NDA201820 | Tobramycin BETHKIS | Chiesi |
| October 14, 2011 | NDA021825 | Deferiprone FERRIPROX | Chiesi |
| August 1, 2008 | NDA022156 | Clevipidine CLEVIPREX | Chiesi |
| November 18, 1999 | BLA020744 | Poractant alfa CUROSURF | Chiesi USA Inc |
| December 9, 1996 | NDA020471 | Zileuton ZYFLO | Chiesi |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
August 19, 2026 · Class III · Ongoing · D-0838-2026 · Elapegademase-lvlr
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
-
July 6, 2026 · Class II · Ongoing · D-0689-2026 · Clevipidine
Lack of Assurance of Sterility
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
-
March 17, 2026 · Class II · Ongoing · D-0402-2026 · Poractant alfa
Lack of Assurance of Sterility
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026