CLASS II Drug recall · Reported 27 Sep 2017 · FDA Enforcement Report
Procrit (epoetin alfa)/mL recalled by Amgen
Amgen is recalling Procrit (epoetin alfa)/mL, distributed nationwide in the US. The recall was initiated on 13 Sep 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-1173-2017
- FDA event ID
- 78110
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Procrit
- Manufacturer
- Janssen Products, LP
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2017
- FDA classified
- 19 Sep 2017
- Reported
- 27 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Sep 2017 | Recall initiated by company | |
| 19 Sep 2017 | Classified by FDA | +6 days |
| 27 Sep 2017 | Published in enforcement report | +8 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: glass flakes identified as lamellae observed during a routine quality inspection.
Product as listed by the FDA
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 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Which lots are affected?
Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18
Where was it sold?
U.S.A. Nationwide
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.
More recalls from Amgen
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 60mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide |
Other Erythropoietin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Procrit Epoetin Alfa/mL single use vial For Intravenouse recalledProcrit | Amgen | Particulate Matter | PR |