FDA Recall D-922-2013
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1000 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, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
Reason for recall
Presence of Particulate Matter; product may contain fibrous material
Recall record
- Recall number
D-922-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2012-08-31
- Classified by FDA Center
- 2013-08-26
- FDA published
- 2013-09-04
- Terminated
- 2015-05-28
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL