Class II · Moderate risk
Procrit (epoetin alfa)
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Procrit Epoetin Alfa 40 (Erythropoietin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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, NDC 59676-340-01
Affected NDC
59676-0340-01
Compare with the code on your package — it is the most precise check available.
Drug: Epoetin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Procrit Erythropoietin NDC 59676-0340 |
EPOETIN 40000 [iU]/mL | Injection, Solution Intravenous|subcutaneous |
Janssen Products, LP | Rx |
- Recalling firm
- Amgen, Inc.
- NDC code
- 59676-340-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1086-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epoetin recalls
See all
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of Particulate Matter: glass delamination
Other recalls by Amgen, Inc.
All 2017 recalls
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Corlanor (ivabradine)
Presence of Foreign Substance.
Class II · Moderate risk
Sensipar (cinacalcet)
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Class II · Moderate risk
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CGMP Deviations
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