Status
Terminated
Drug Enforcement D-023-2014
Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Classification
Class II
Report Date
December 11, 2013
Termination Date
October 28, 2014
Product Information
- Product description
- Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA.
- Product quantity
- 29,700 vials
- Reason for recall
- Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira, Inc.
- Address
-
600 N Field Dr Bldg J45, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-023-2014
- Event ID
- 66435
- Recall initiation date
- September 16, 2013
- Center classification date
- December 2, 2013
- Code info
- Lot #17368EV Exp 08/13
- More code info
- —