Erythropoiesis-stimulating Agent
Where is Epoetin made?
3 companies sell it under their own name. Their labels name 4 factories in the United States.
United States 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Products LP Procrit2000 [iU] per 1 mL, 3000 [iU] per 1 mL, 4000 [iU] per 1 mL, 10000 [iU] per 1 mL, 20000 [iU] per 1 mL, 40000 [iU] per 1 mL · NDC 59676-310, 59676-312, 59676-302 +4 | Amgen Manufacturing Limited LLCMakes it and tests it | Juncos, PR, United States | Problems found, fixed voluntarilyApr 2026 |
| Amgen, IncMakes it and tests it | Thousand Oaks, CA, United States | No problems foundAug 2025 | |
| Patheon Manufacturing Services LLCMakes it and tests it | Greenville, NC, United States | No problems foundSep 2025 | |
| Vifor (International) Inc. Retacrit2000 [iU] per 1 mL, 3000 [iU] per 1 mL, 4000 [iU] per 1 mL, 10000 [iU] per 1 mL, 20000 [iU] per 1 mL · NDC 59353-010, 59353-220, 59353-002 +3 | Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 |
| Amgen Inc Epogen2000 [iU] per 1 mL, 3000 [iU] per 1 mL, 4000 [iU] per 1 mL, 10000 [iU] per 1 mL, 20000 [iU] per 1 mL · NDC 55513-144, 55513-283, 55513-126 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Sep 13, 2017 · Class II · Amgen, Inc.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. - Aug 4, 2017 · Class II · Amgen, Inc.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.