Drug recall
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25…
FDA recall event 84833 · Class II · Pfizer Inc.
Key facts
| Event ID | 84833 |
|---|---|
| Recall numbers | D-0835-2020 |
| Recalling firm | Pfizer Inc. |
| Product type | Drugs |
| Products | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility. |
| Initiation date | Feb 3, 2020 |
| Report date | Feb 19, 2020 |
| Termination date | Sep 29, 2022 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2416101 |
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: