Drug recall
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02)…
FDA recall event 77319 · Class III · VistaPharm, Inc.
Key facts
| Event ID | 77319 |
|---|---|
| Recall numbers | D-0869-2017 |
| Recalling firm | VistaPharm, Inc. |
| Product type | Drugs |
| Products | Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. |
| Initiation date | May 17, 2017 |
| Report date | Jun 7, 2017 |
| Termination date | Jan 13, 2020 |
| 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: