Drug recall
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC…
FDA recall event 62421 · Class II · VistaPharm, Inc.
Key facts
| Event ID | 62421 |
|---|---|
| Recall numbers | D-1440-2012 |
| Recalling firm | VistaPharm, Inc. |
| Product type | Drugs |
| Products | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The… |
| Initiation date | Sep 30, 2011 |
| Report date | Aug 8, 2012 |
| Termination date | Dec 12, 2013 |
| City | Largo |
| State | FL |
| Country | United States |
| FEI number | 1036352 |
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 · Source date: