Drug recall
Adagen (pegademase bovine) injection, four 1.5 ml single-dose vials, 250 units per mL, sterile, refrigerate…
FDA recall event 51549 · Class II · Enzon Pharmaceuticals, Inc.
Key facts
| Event ID | 51549 |
|---|---|
| Recall numbers | D-1227-2009 |
| Recalling firm | Enzon Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Adagen (pegademase bovine) injection, four 1.5 ml single-dose vials, 250 units per mL, sterile, refrigerate, Rx only, Enzon Pharmaceuticals, Inc., Bridgewater, NJ; NDC 57665-001-01. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Exceeded Impurity Specification; 6 month stability testing. |
| Initiation date | Mar 27, 2009 |
| Termination date | Dec 7, 2009 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1000517970 |
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