Drug recall
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, packaged in a) 30-count tablets per bottle (NDC…
FDA recall event 61548 · Class III · Actavis South Atlantic LLC
Key facts
| Event ID | 61548 |
|---|---|
| Recall numbers | D-1328-2012, D-1329-2012 |
| Recalling firm | Actavis South Atlantic LLC |
| Product type | Drugs |
| Products | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, packaged in a) 30-count tablets per bottle (NDC 67767-141-30), b) 90-count tablets per bottle (NDC 67767-141-90), Rx only, labels may…, buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, packaged in a) 30-count tablets per bottle (NDC 67767-142-30), b) 90-count tablets per bottle (NDC 67767-142-90), c) 500-count tablets… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Out of specification results for dissolution were obtained at the 8-hour stability testing point, all other time points at 2, 3, and 16-hours met… |
| Initiation date | Dec 27, 2011 |
| Termination date | Feb 26, 2013 |
| 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