Drug recall
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL)…
FDA recall event 63198 · Class II · Hospira Inc.
Key facts
| Event ID | 63198 |
|---|---|
| Recall numbers | D-1685-2012 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. |
| Initiation date | Aug 29, 2012 |
| Report date | Oct 3, 2012 |
| Termination date | Aug 8, 2013 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3005579246 |
At a glance
- 1–9 Products in this recall
- None 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: