D-309-2013 Class II Terminated
FDA drug recall D-309-2013 was initiated by Hospira Inc. on Aug 28, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. The recall status is terminated (terminated Sep 18, 2014). Affected quantity: 172,350 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2013
- Initiation Date
- Aug 28, 2012
- Termination Date
- Sep 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172,350 vials
Product Description
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 17-100-EV and 17-399-EV
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-309-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026