Drug recall
Doxorubicin Hydrochloride Injection, USP, 200mg/100mL (2mg/mL), 100mL Multiple Dose Vial, For Intravenous Use…
FDA recall event 25003 · Class III · GensiaSicor Pharmaceuticals
Key facts
| Event ID | 25003 |
|---|---|
| Recall numbers | D-098-3 |
| Recalling firm | GensiaSicor Pharmaceuticals |
| Product type | Drugs |
| Products | Doxorubicin Hydrochloride Injection, USP, 200mg/100mL (2mg/mL), 100mL Multiple Dose Vial, For Intravenous Use Only, Rx Only, Gensia Sicor Pharmaceuticals, Inc., Irvine, CA 92618 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeled; outer carton incorrectly labeled as Single Dose Vial rather than correctly as Multiple Dose Vial |
| Initiation date | Nov 12, 2002 |
| City | Irvine |
| Country | United States |
| FEI number | 2027158 |
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