Drug recall
Epogen (epoetin alfa) recombinant Injection, 20,000 Units/2 mL (10,000 Units/mL), 2 mL Multidose Vials (NDC…
FDA recall event 57444 · Class II · Amgen, Inc.
Key facts
| Event ID | 57444 |
|---|---|
| Recall numbers | D-392-2011, D-393-2011, D-394-2011, D-395-2011 |
| Recalling firm | Amgen, Inc. |
| Product type | Drugs |
| Products | Epogen (epoetin alfa) recombinant Injection, 20,000 Units/2 mL (10,000 Units/mL), 2 mL Multidose Vials (NDC 55513-283-01), packaged in 10 x 2 mL Multidose Vials (NDC 55513-283-10; UPC 3 55513 28310…, Epogen (epoetin alfa) recombinant Injection, 20,000 Units/mL, 1 mL Multidose Vials (NDC 55513-478-01), packaged in 10 x 20,000 Units/mL Multidose Vials (NDC 55513-478-10; UPC 3 55513 47810 6); Rx…, Epogen (epoetin alfa) recombinant Injection, 3000 Units/mL, 1 mL Single Use Vials (NDC 55513-267-01), packaged in 10 x 3000 Units/mL Single Use Vials per carton (NDC 55513-267-10, UPC 3 55513 26710…, Epogen (epoetin alfa) recombinant Injection, 4000 Units/mL, 1 mL Single Use Vials (NDC 55513-148-01), packaged in 10 x 4000 Units/mL Single Use Vials per carton (NDC 55513-148-10, UPC 3 55513 14810… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: due to the presence of glass flakes, that are extremely difficult to see, discovered in a number of vials. |
| Initiation date | Nov 16, 2010 |
| Termination date | Feb 14, 2012 |
| 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