D-314-2013 Class II Terminated
FDA drug recall D-314-2013 was initiated by Hospira Inc. on Feb 26, 2013 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 Nov 10, 2014). Affected quantity: 259,050 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2013
- Initiation Date
- Feb 26, 2013
- Termination Date
- Nov 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 259,050 vials
Product Description
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 20-564-DK Exp. 02/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-314-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026