Recalls / Class II
Class IID-0294-2015
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- 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 41-099-DK, exp 01MAY2016, NDC 0409-9094-61
Why it was recalled
Lack of Assurance of Sterility; improperly crimped fliptop vials
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, N/A, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 62,650 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-03
- FDA classified
- 2014-12-10
- Posted by FDA
- 2014-12-17
- Terminated
- 2015-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0294-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.