Drug recall
Seroquel XR (quetiapine fumarate) extended-release tablets, 50 mg, Once Daily, Professional Sample, Not to be…
FDA recall event 51452 · Class III · AstraZeneca Pharmaceuticals LP
Key facts
| Event ID | 51452 |
|---|---|
| Recall numbers | D-233-2009 |
| Recalling firm | AstraZeneca Pharmaceuticals LP |
| Product type | Drugs |
| Products | Seroquel XR (quetiapine fumarate) extended-release tablets, 50 mg, Once Daily, Professional Sample, Not to be sold, Rx only, supplied in four tablet blister card, one card per carton, Manufactured for… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The incorrect Product Insert (Prescribing Information) was included with shipments of Seroquel XR 50 mg samples. |
| Initiation date | Mar 6, 2009 |
| Termination date | Aug 18, 2009 |
| City | Wilmington |
| State | DE |
| Country | United States |
| FEI number | 1000522430 |
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