Drug recall
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only…
FDA recall event 65784 · Class II · Baxter Healthcare Corp.
Key facts
| Event ID | 65784 |
|---|---|
| Recall numbers | D-831-2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Product type | Drugs |
| Products | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed. |
| Initiation date | Jul 24, 2013 |
| Report date | Aug 7, 2013 |
| Termination date | Jun 24, 2014 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
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: