D-023-2014 Class II Terminated
FDA drug recall D-023-2014 was initiated by Hospira, Inc. on Sep 16, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck. The recall status is terminated (terminated Oct 28, 2014). Affected quantity: 29,700 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 11, 2013
- Initiation Date
- Sep 16, 2013
- Termination Date
- Oct 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,700 vials
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.
Reason for Recall
Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.
Distribution Pattern
Nationwide
Code Information
Lot #17368EV Exp 08/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-023-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026