D-297-2013 Class II Terminated
FDA drug recall D-297-2013 was initiated by Hospira Inc. on Apr 8, 2013 and is designated Class II. Reason for recall: Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. The recall status is terminated (terminated Nov 3, 2014). Affected quantity: 245,250 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- Apr 8, 2013
- Termination Date
- Nov 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 245,250 vials
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Reason for Recall
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-297-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026