Drug recall
Intralipid 10%, a 10% Fat Emulsion for Intravenous Use, 500 mL flexible plastic container, sterile, Rx only…
FDA recall event 47379 · Class II · Baxter Healthcare Corp.
Key facts
| Event ID | 47379 |
|---|---|
| Recall numbers | D-211-2008, D-212-2008, D-213-2008 |
| Recalling firm | Baxter Healthcare Corp. |
| Product type | Drugs |
| Products | Intralipid 10%, a 10% Fat Emulsion for Intravenous Use, 500 mL flexible plastic container, sterile, Rx only, each 100 mL contains Soybean Oil 10 g, Phospholipids 1.2 g, Glycerin USP 2.25 g, NDC…, Intralipid 20%, a 20% Fat Emulsion for Intravenous Use, 100, 250, 500 mL flexible plastic containers, sterile, Rx only, each 100 mL contains Soybean Oil 20 g, Phospholipids 1.2 g, Glycerin USP 2.25 g…, Intralipid 30%, a 30% Fat Emulsion for Intravenous Use, 500 mL flexible plastic container, Pharmacy Bulk Package, sterile, Rx only, each 100 mL contains Soybean Oil 30 g, Phospholipids 1.2 g, Glycerin… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an increased potential for port splitting to occur in the administration port. |
| Initiation date | Mar 11, 2008 |
| Termination date | May 13, 2010 |
| City | Round Lake |
| State | IL |
| Country | United States |
| FEI number | 1416980 |
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