Drug recall
Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC…
FDA recall event 75640 · Class II · VistaPharm, Inc.
Key facts
| Event ID | 75640 |
|---|---|
| Recall numbers | D-0469-2017 |
| Recalling firm | VistaPharm, Inc. |
| Product type | Drugs |
| Products | Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Container: Leakage of unit dose cups that may occur at the seal. |
| Initiation date | Jan 18, 2017 |
| Report date | Feb 15, 2017 |
| 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: