Drug recall
Oncaspar (Pegaspargase), Lot (1unit dose per unit package) BLA STN 103411, 750 I.U. per mL, Sterile, Enzon…
FDA recall event 34838 · Class II · Enzon Pharmaceuticals, Inc
Key facts
| Event ID | 34838 |
|---|---|
| Recall numbers | D-216-6 |
| Recalling firm | Enzon Pharmaceuticals, Inc |
| Product type | Drugs |
| Products | Oncaspar (Pegaspargase), Lot (1unit dose per unit package) BLA STN 103411, 750 I.U. per mL, Sterile, Enzon Pharmaceuticals, Inc., Bridgewater, NJ 08807, NDC 57665-002-02. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent: At the 18 month stability station, the enzymatic activity is above specification coming in at 907 IU/mL. (Spec. 600-900 IU/mL). |
| Initiation date | Mar 13, 2006 |
| City | South Plainfield |
| Country | United States |
| FEI number | 2245253 |
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