CLASS II Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Procrit Epoetin Alfa/mL single use vial For Intravenouse recalled
Amgen is recalling Procrit Epoetin Alfa/mL single use vial For Intravenouse or Subcutaneous Use Only, distributed in Puerto Rico. The recall was initiated on 4 Aug 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1086-2017
- FDA event ID
- 77889
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Procrit
- Manufacturer
- Janssen Products, LP
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2017
- FDA classified
- 14 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Aug 2017 | Recall initiated by company | |
| 14 Aug 2017 | Classified by FDA | +10 days |
| 23 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Product as listed by the FDA
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
Where it was distributed
United States including Puerto Rico
Questions about this recall
Why was it recalled?
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Which lots are affected?
Lot #: G290491A, G290491B, Exp. 06/18
Where was it sold?
United States including Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Erythropoietin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Procrit (epoetin alfa)/mL recalled by AmgenProcrit | Amgen | Particulate Matter | Nationwide |