Status
Terminated
Drug Enforcement D-502-2013
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Classification
Class II
Report Date
June 12, 2013
Termination Date
October 8, 2014
Product Information
- Product description
- DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
- Product quantity
- 44,748 bags
- Reason for recall
- Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
- 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-502-2013
- Event ID
- 65225
- Recall initiation date
- April 30, 2013
- Center classification date
- June 3, 2013
- Code info
- Lot 11-309-KL
- More code info
- —