Recalls / Class II
Class IID-169-2013
Product
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
- Brand name
- Furosemide
- Generic name
- Furosemide
- Active ingredient
- Furosemide
- Route
- Intramuscular, Intravenous
- NDC
- 0409-6102
- FDA application
- NDA018667
- Affected lot / code info
- 18-099-DK
Why it was recalled
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Hwy. 301 N. + 4285 North Wesleyan Blvd., N/A, Rocky Mount, North Carolina 27804
Distribution
- Quantity
- 63,900 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-10
- FDA classified
- 2013-02-26
- Posted by FDA
- 2013-03-06
- Terminated
- 2014-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-169-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.