FDA Recall D-0969-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 728 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Reason for recall
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Recall record
- Recall number
D-0969-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-01-20
- Classified by FDA Center
- 2015-04-23
- FDA published
- 2015-04-29
- Terminated
- 2017-01-17
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL