Drug recall
Actavis Twice a Day buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets NDC…
FDA recall event 53036 · Class II · Actavis South Atlantic LLC
Key facts
| Event ID | 53036 |
|---|---|
| Recall numbers | D-1896-2009 |
| Recalling firm | Actavis South Atlantic LLC |
| Product type | Drugs |
| Products | Actavis Twice a Day buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets NDC 67767-133-60, Lot #0805699A.*** Distributed by:Actavis South Atlantic LLC |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Actavis South-Atlantic is voluntarily recalling Bupropion HCL 150mg SR Tablets lot # 0805699A due to the lot not meeting stability specifications for a known impurity, m-chlorobenzoic acid. |
| Initiation date | Jun 15, 2009 |
| Termination date | Jan 5, 2010 |
| City | Sunrise |
| State | FL |
| Country | United States |
| FEI number | 3004090892 |
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