Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Reported: November 30, 2016 Initiated: November 1, 2016 #D-0153-2017
Product Description
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Reason for Recall
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 797,800 ampules
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32. Recalled by Hospira Inc.. Units affected: 797,800 ampules.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Moderate. Recall number: D-0153-2017.
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