FDAFDA · Food and drugs·Recall number D-0835-2020
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, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Published February 19, 2020 · Recall initiated: February 3, 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
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide in the U.S. and Puerto Rico
- Lot
- Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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