FDAFDA · Food and drugs·Recall number D-1446-2020
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Published August 12, 2020 · Recall initiated: July 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FENTANYL CITRATE
- Manufacturer
- Pfizer Inc.
- Distributor
- United States including Puerto Rico
- Lot
- Lots: Tray lot: 13405DK Vial lot: 13-405 DK Exp. 1JUL2021, Tray lot: 17096DK Vial lot: 17-096-DK Exp. 1NOV2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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