Drug recall
Vimovo (naproxen/esomeprazole magnesium), 500 mg/20 mg delayed release tablets, Rx only, Manufactured for…
FDA recall event 59169 · Class II · AstraZeneca Pharmaceuticals LP
Key facts
| Event ID | 59169 |
|---|---|
| Recall numbers | D-921-2011 |
| Recalling firm | AstraZeneca Pharmaceuticals LP |
| Product type | Drugs |
| Products | Vimovo (naproxen/esomeprazole magnesium), 500 mg/20 mg delayed release tablets, Rx only, Manufactured for: AstraZeneca, LP, Wilmington, DE, By: Patheon Pharmaceuticals, Inc., Cincinnati, OH |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specification |
| Initiation date | Jun 28, 2011 |
| Termination date | Jun 21, 2012 |
| City | Wilmington |
| State | DE |
| Country | United States |
| FEI number | 2518137 |
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