Drug recall
Budeprion SR (Bupropion HCl) Extended-Release Tablets, 150 mg, 100-tablet bottles, Rx only, NDC 0093-5502-01…
FDA recall event 45989 · Class III · Teva Pharmaceuticals USA
Key facts
| Event ID | 45989 |
|---|---|
| Recall numbers | D-086-2008 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Budeprion SR (Bupropion HCl) Extended-Release Tablets, 150 mg, 100-tablet bottles, Rx only, NDC 0093-5502-01. Manufactured by IMPAX Laboratories, Inc., Hayward, CA, for Teva Pharmaceuticals USA… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product does not meet time-release dissolution specifications. |
| Initiation date | Nov 28, 2007 |
| Termination date | Nov 12, 2008 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
At a glance
- 1–9 Products in this recall
- 1–9 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