Drug recall
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake…
FDA recall event 75619 · Class II · Hospira Inc.
Key facts
| Event ID | 75619 |
|---|---|
| Recall numbers | D-0153-2017 |
| Recalling firm | Hospira Inc. |
| Product type | Drugs |
| Products | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Complaints of broken tips on the ampules. |
| Initiation date | Nov 1, 2016 |
| Report date | Nov 30, 2016 |
| Termination date | Aug 28, 2018 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3004591926 |
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: