Drug recall
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose…
FDA recall event 70050 · Class II · Fresenius Kabi USA, LLC
Key facts
| Event ID | 70050 |
|---|---|
| Recall numbers | Z-1032-2015 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Devices |
| Products | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The lot failed pH specification. |
| Initiation date | Dec 19, 2014 |
| Report date | Feb 4, 2015 |
| Termination date | Jan 26, 2016 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3002733956 |
At a glance
- 1–9 Products in this recall
- 1–9 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: