Status
Terminated
Drug Enforcement D-169-2013
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Classification
Class II
Report Date
March 6, 2013
Termination Date
October 8, 2014
Product Information
- Product description
- Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
- Product quantity
- 63,900 vials
- Reason for recall
- Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira, Inc.
- Address
-
Hwy. 301 N. + 4285 North Wesleyan Blvd., N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-169-2013
- Event ID
- 64083
- Recall initiation date
- January 10, 2013
- Center classification date
- February 26, 2013
- Code info
- 18-099-DK
- More code info
- —