Class II
Terminated
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).
- Company
- Pfizer Inc.
- Recall Initiated
- February 3, 2020
- Posted
- February 19, 2020
- Recall Number
- D-0835-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 38,676 trays
- Firm Location
- New York, NY, United States
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.
Distribution
Nationwide in the U.S. and Puerto Rico
Lot / Code Info
Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.
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