Status
Terminated
Drug Enforcement D-314-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Classification
Class II
Report Date
May 15, 2013
Termination Date
November 10, 2014
Product Information
- Product description
- Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
- Product quantity
- 259,050 vials
- Reason for recall
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-314-2013
- Event ID
- 65077
- Recall initiation date
- February 26, 2013
- Center classification date
- May 6, 2013
- Code info
- Lot 20-564-DK Exp. 02/14
- More code info
- —