Status
Terminated
Drug Enforcement D-927-2013
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Classification
Class II
Report Date
September 4, 2013
Termination Date
October 28, 2014
Product Information
- Product description
- Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
- Product quantity
- 72,300 vials
- Reason for recall
- Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-927-2013
- Event ID
- 66104
- Recall initiation date
- August 16, 2013
- Center classification date
- August 28, 2013
- Code info
- Lot: 23-505-EV, Exp. 11/14
- More code info
- —