D-308-2013 Class II Terminated
FDA drug recall D-308-2013 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: 26,100 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
- 26,100 vials
Product Description
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 15-065-DK, Exp 1SEP2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-308-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026