D-1547-2014 Class I Terminated
FDA drug recall D-1547-2014 was initiated by Hospira Inc. on Apr 2, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and… The recall status is terminated (terminated May 29, 2015). Affected quantity: 844,300 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 27, 2014
- Initiation Date
- Apr 2, 2014
- Termination Date
- May 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 844,300 vials
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Reason for Recall
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Distribution Pattern
Nationwide
Code Information
Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1547-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026