Drug recall
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech…
FDA recall event 72912 · Class II · Teva North America
Key facts
| Event ID | 72912 |
|---|---|
| Recall numbers | D-0732-2016 |
| Recalling firm | Teva North America |
| Product type | Drugs |
| Products | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: low test results at the 18 month time-point |
| Initiation date | Dec 21, 2015 |
| Report date | Mar 9, 2016 |
| Termination date | Jan 13, 2017 |
| City | Horsham |
| State | PA |
| Country | United States |
| FEI number | 3008430772 |
At a glance
- 1–9 Products in this recall
- None 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: