Drug recall
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047…
FDA recall event 73652 · Class III · Fresenius Kabi USA, LLC
Key facts
| Event ID | 73652 |
|---|---|
| Recall numbers | D-0818-2016 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Drugs |
| Products | Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. |
| Initiation date | Apr 7, 2016 |
| Report date | Apr 20, 2016 |
| Termination date | Nov 7, 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: