Recalls / Class II
Class IID-1433-201
Product
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.
- Brand name
- Fentanyl Citrate
- Generic name
- Fentanyl Citrate
- Active ingredient
- Fentanyl Citrate
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-9094, 0409-9093
- FDA application
- NDA019115
- Affected lot / code info
- Lot #: 39474DK, Expiry: 03/01/2016.
Why it was recalled
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 47,400 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-06-27
- FDA classified
- 2014-07-14
- Posted by FDA
- 2014-07-23
- Terminated
- 2015-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1433-201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.