Drug recall
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b)…
FDA recall event 66961 · Class III · Actavis Inc
Key facts
| Event ID | 66961 |
|---|---|
| Recall numbers | D-1043-2014 |
| Recalling firm | Actavis Inc |
| Product type | Drugs |
| Products | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. |
| Initiation date | Nov 15, 2013 |
| Report date | Feb 5, 2014 |
| Termination date | Jun 16, 2015 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3010259842 |
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 · Source date: