Drug recall
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial…
FDA recall event 67936 · Class I · Hospira Inc.
Key facts
| Event ID | 67936 |
|---|---|
| Recall numbers | D-1547-2014 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and… |
| Initiation date | Apr 2, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | May 29, 2015 |
| 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: