Drug recall
Xeloda (capecitabine) Tablets, each tablet contains 500 mg, Rx only, bottles of 120, Distributed by Genentech…
FDA recall event 58244 · Class II · Genentech Inc
Key facts
| Event ID | 58244 |
|---|---|
| Recall numbers | D-553-2011 |
| Recalling firm | Genentech Inc |
| Product type | Drugs |
| Products | Xeloda (capecitabine) Tablets, each tablet contains 500 mg, Rx only, bottles of 120, Distributed by Genentech USA, Inc. a Member of the Roche Group South San Francisco, CA 94080 --- NDC 0004-1101-50 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Chemical contamination; presence of low levels of naphthalene and/or 1,4 dichlorobenzene causing an off odor |
| Initiation date | Mar 21, 2011 |
| Termination date | Mar 4, 2013 |
| City | South San Francisco |
| State | CA |
| Country | United States |
| FEI number | 2917293 |
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