Drug recall
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only…
FDA recall event 77889 · Class II · Amgen, Inc.
Key facts
| Event ID | 77889 |
|---|---|
| Recall numbers | D-1086-2017 |
| Recalling firm | Amgen, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. |
| Initiation date | Aug 4, 2017 |
| Report date | Aug 23, 2017 |
| Termination date | Mar 29, 2018 |
| City | Thousand Oaks |
| State | CA |
| Country | United States |
| FEI number | 2026154 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: