Janssen Products, LP
NDC labeler code: 59676
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
- Epoetin alfa-epbxRetacrit, Procrit, Epogen · 7 products
- DarunavirPrezista · 5 products
- ErdafitinibBalversa · 3 products
- EtravirineIntelence · 3 products
- Darunavir ethanolate and cobicistatPrezcobix, Prezcobix Ped · 3 products
- ApalutamideErleada · 2 products
- Rilpivirine hydrochlorideEdurant Ped, Edurant · 2 products
- Bedaquiline fumarateSirturo · 2 products
- Darunavir, cobicistat, emtricitabine, and tenofovir alafenamideSymtuza · 1 product
- TrabectedinYondelis, Evdi · 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 |
|---|---|---|---|
| February 27, 2026 | NDA220092 | Darunavir ethanolate and cobicistat PREZCOBIX, PREZCOBIX PED | Janssen Prods |
| March 15, 2024 | NDA219016 | Rilpivirine hydrochloride EDURANT PED | Janssen Prods |
| April 12, 2019 | NDA212018 | Erdafitinib BALVERSA | Janssen Biotech |
| July 17, 2018 | NDA210455 | Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide SYMTUZA | Janssen Prods |
| February 14, 2018 | NDA210951 | Apalutamide ERLEADA | Janssen Biotech |
| October 23, 2015 | NDA207953 | Trabectedin YONDELIS | Janssen Prods |
| January 29, 2015 | NDA205395 | Darunavir ethanolate and cobicistat PREZCOBIX | Janssen Prods |
| December 28, 2012 | NDA204384 | Bedaquiline fumarate SIRTURO | Janssen Therap |
| December 16, 2011 | NDA202895 | Darunavir PREZISTA | Janssen Prods |
| May 20, 2011 | NDA202022 | Rilpivirine hydrochloride EDURANT | Janssen Prods |
| January 18, 2008 | NDA022187 | Etravirine INTELENCE | Janssen R and D |
| June 23, 2006 | NDA021976 | Darunavir PREZISTA | Janssen Prods |
| June 1, 1989 | BLA103234 | Epoetin alfa-epbx EPOGEN/PROCRIT | Amgen |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2017
-
September 13, 2017 · Class II · Terminated · D-1173-2017 · Epoetin alfa-epbx
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91
-
August 4, 2017 · Class II · Terminated · D-1086-2017 · Epoetin alfa-epbx
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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