Drug recall
Budeprion XL (Bupropion HCl ER Tablets) 300 mg, RX only, 500 tablets, manufactured by Impax Laboratories, Inc…
FDA recall event 57849 · Class III · Teva Pharmaceuticals USA, Inc.
Key facts
| Event ID | 57849 |
|---|---|
| Recall numbers | D-225-2012 |
| Recalling firm | Teva Pharmaceuticals USA, Inc. |
| Product type | Drugs |
| Products | Budeprion XL (Bupropion HCl ER Tablets) 300 mg, RX only, 500 tablets, manufactured by Impax Laboratories, Inc. Hayward, CA, NDC # 0093-5351-05. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: Firm was notified by manufacturer of their intent to voluntarily recall the indicated lots of product distributed by Teva. Recall is being carried out due to the… |
| Initiation date | Jan 31, 2011 |
| Termination date | Aug 16, 2012 |
| City | Sellersville |
| State | PA |
| Country | United States |
| FEI number | 2517175 |
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