Drug recall
Temodar (temozolomide capsules), 5 mg per capsule, 5-count bottle, Rx Only, Cytotoxic, Schering Corporation…
FDA recall event 61225 · Class II · Schering-Plough Products, LLC
Key facts
| Event ID | 61225 |
|---|---|
| Recall numbers | D-1293-2012 |
| Recalling firm | Schering-Plough Products, LLC |
| Product type | Drugs |
| Products | Temodar (temozolomide capsules), 5 mg per capsule, 5-count bottle, Rx Only, Cytotoxic, Schering Corporation, Kenilworth NJ 07033, NDC 0085-3002-02 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: This recall is due to an out of specification result relating to total degradation products detected during stability testing. |
| Initiation date | Feb 27, 2012 |
| Termination date | Sep 23, 2013 |
| City | Las Piedras |
| State | PR |
| Country | United States |
| FEI number | 2650155 |
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