Drug recall
Procrit (epoetin alfa) 10,000 U/mL, 4 x 2mL Multidose Vials, Sterile, Rx only, Manufactured by Amgen Inc., US…
FDA recall event 49091 · Class II · Gbsc
Key facts
| Event ID | 49091 |
|---|---|
| Recall numbers | D-128-2009 |
| Recalling firm | Gbsc |
| Product type | Drugs |
| Products | Procrit (epoetin alfa) 10,000 U/mL, 4 x 2mL Multidose Vials, Sterile, Rx only, Manufactured by Amgen Inc., US, Thousand Oaks, CA ---- NDC 59676-312-04 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of assurance of sterility; vials have cracks at the neck |
| Initiation date | Aug 5, 2008 |
| Termination date | May 6, 2009 |
| City | Horsham |
| State | PA |
| Country | United States |
| FEI number | 3006240615 |
At a glance
- 1–9 Products in this recall
- None 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