Drug recall
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie…
FDA recall event 78286 · Class III · Genzyme Corporation
Key facts
| Event ID | 78286 |
|---|---|
| Recall numbers | D-0075-2018 |
| Recalling firm | Genzyme Corporation |
| Product type | Drugs |
| Products | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Package Insert. |
| Initiation date | Oct 12, 2017 |
| Report date | Nov 22, 2017 |
| Termination date | Sep 10, 2020 |
| City | Northborough |
| State | MA |
| Country | United States |
| FEI number | 3009389940 |
At a glance
- 1–9 Products in this recall
- 1–9 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 · Source date: