FDA Recall D-1547-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 422 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1547-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2014-04-02
- Classified by FDA Center
- 2014-08-20
- FDA published
- 2014-08-27
- Terminated
- 2015-05-29
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- PROPOFOL
- Generic name(s)
- PROPOFOL
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-4699, 0409-6010- Route(s)
- INTRAVENOUS