Recalls / Class II
Class IID-0153-2017
Product
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
- Affected lot / code info
- Lot #5 9277EV, 60028EV, 6008EV, Exp 11/1/17
Why it was recalled
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 797,800 ampules
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-01
- FDA classified
- 2016-11-23
- Posted by FDA
- 2016-11-30
- Terminated
- 2018-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0153-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.