Drug recall
Enablex (darifenacin) Extended-release tablets, 15 mg per tablet, 30 Tablet bottle, Rx only, NOVARTISl, Mfd…
FDA recall event 59318 · Class III · Novartis Pharmaceuticals Corp.
Key facts
| Event ID | 59318 |
|---|---|
| Recall numbers | D-762-2011 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Enablex (darifenacin) Extended-release tablets, 15 mg per tablet, 30 Tablet bottle, Rx only, NOVARTISl, Mfd. by: Novartis Pharma Stein AG Stein, Switzerland for Novartis Pharm. Corp. East Hanover, NJ… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Enablex 15 mg Tablets, Lot F0064 was found to be out of specification (OOS) for dissolution at 8 hours. All other dissolution time points (at 1 hour and 24… |
| Initiation date | Jun 30, 2011 |
| Termination date | Sep 25, 2012 |
| City | Suffern |
| State | NY |
| Country | United States |
| FEI number | 2416082 |
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