FDA Recall D-0976-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 462 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, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Reason for recall
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Recall record
- Recall number
D-0976-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide.
- Recall initiated
- 2015-03-05
- Classified by FDA Center
- 2015-05-04
- FDA published
- 2015-05-13
- Terminated
- 2016-06-09
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL