D-1033-2014 Class II Terminated
FDA drug recall D-1033-2014 was initiated by Hospira Inc. on Dec 12, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for… The recall status is terminated (terminated Oct 16, 2014). Affected quantity: 126,425 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 29, 2014
- Initiation Date
- Dec 12, 2013
- Termination Date
- Oct 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126,425 vials
Product Description
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Reason for Recall
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Distribution Pattern
Nationwide
Code Information
Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1033-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026