D-927-2013 Class II Terminated
FDA drug recall D-927-2013 was initiated by Hospira Inc. on Aug 16, 2013 and is designated Class II. Reason for recall: Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 72,300 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 4, 2013
- Initiation Date
- Aug 16, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72,300 vials
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
Reason for Recall
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot: 23-505-EV, Exp. 11/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-927-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026