NDC 54868-5802
Procrit 40000 [iU] per 1 mL injection, solution
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Janssen Products LP's NDC 59676-340.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amgen Manufacturing Limited LLC | Juncos, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyApr 27, 2026 · 18 inspections |
| Amgen, Inc | Thousand Oaks, CA, United States | Makes it and tests it | No problems foundAug 7, 2025 · 23 inspections |
| Patheon Manufacturing Services LLC | Greenville, NC, United States | Makes it and tests it | No problems foundSep 26, 2025 · 11 inspections |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
Recalls
- Sep 13, 2017 · Class II · Amgen, Inc.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Lots: Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18 - Aug 4, 2017 · Class II · Amgen, Inc.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Lots: Lot #: G290491A, G290491B, Exp. 06/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Erythropoietin: every company that makes it
- Form
- injection, solution
- Strength
- 40000 [iU] per 1 mL
- Approval
- BLA BLA103234
- On the market since
- Aug 13, 2007
- Package NDCs
54868-5802-0- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2013
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