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).
Reported: February 19, 2020 Initiated: February 3, 2020 #D-0835-2020
Product Description
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).
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 38,676 trays
- Distribution
- Nationwide in the U.S. and Puerto Rico
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Pfizer Inc.. Units affected: 38,676 trays.
Why was this product recalled? ▼
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0835-2020.
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