Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Reported: July 23, 2014 Initiated: June 27, 2014 #D-1433-201
Product Description
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Reason for Recall
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 47,400 vials
- Distribution
- U.S. Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.. Recalled by Hospira Inc.. Units affected: 47,400 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2014. Severity: Moderate. Recall number: D-1433-201.
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