D-0381-2015 Class II Terminated
FDA drug recall D-0381-2015 was initiated by Hospira Inc. on Dec 23, 2014 and is designated Class II. Reason for recall: Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. The recall status is terminated (terminated Jul 30, 2015). Affected quantity: 126,075 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 4, 2015
- Initiation Date
- Dec 23, 2014
- Termination Date
- Jul 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126,075 vials
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Reason for Recall
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Distribution Pattern
Nationwide
Code Information
Lot 35-844-DJ, Exp 11/01/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0381-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026