FDA Recall D-0324-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 480 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
Reason for recall
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Recall record
- Recall number
D-0324-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2014-09-11
- Classified by FDA Center
- 2014-12-23
- FDA published
- 2014-12-31
- Terminated
- 2016-01-04
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- HEPARIN SODIUM
- Generic name(s)
- HEPARIN SODIUM
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-1005, 0409-7620, 0409-2222- Route(s)
- INTRAVENOUS