Drug recall
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30…
FDA recall event 64317 · Class III · Actavis Pharmaceuticals
Key facts
| Event ID | 64317 |
|---|---|
| Recall numbers | D-175-2013 |
| Recalling firm | Actavis Pharmaceuticals |
| Product type | Drugs |
| Products | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. |
| Initiation date | Jan 4, 2013 |
| Report date | Mar 6, 2013 |
| Termination date | Jan 13, 2014 |
| City | Morristown |
| State | NJ |
| Country | United States |
| FEI number | 3009180966 |
At a glance
- 1–9 Products in this recall
- None 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: