Drug recall
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01) Rx Only, Manufactured by VistaPharm…
FDA recall event 65756 · Class II · VistaPharm, Inc.
Key facts
| Event ID | 65756 |
|---|---|
| Recall numbers | D-913-2013 |
| Recalling firm | VistaPharm, Inc. |
| Product type | Drugs |
| Products | Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. |
| Initiation date | Jul 4, 2013 |
| Report date | Aug 28, 2013 |
| Termination date | Aug 4, 2014 |
| 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: