Drug recall
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc…
FDA recall event 68246 · Class II · Forest Pharmaceuticals Inc
Key facts
| Event ID | 68246 |
|---|---|
| Recall numbers | D-1348-2014 |
| Recalling firm | Forest Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life. |
| Initiation date | May 12, 2014 |
| Report date | May 28, 2014 |
| Termination date | Jan 5, 2016 |
| City | Earth City |
| State | MO |
| Country | United States |
| FEI number | 1921065 |
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 · Source date: