FDA Recall D-836-2013
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 843 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, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Reason for recall
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Recall record
- Recall number
D-836-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-03-29
- Classified by FDA Center
- 2013-08-02
- FDA published
- 2013-08-14
- Terminated
- 2015-07-20
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL