FDA Recall D-0392-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 501 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
Reason for recall
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Recall record
- Recall number
D-0392-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2014-07-10
- Classified by FDA Center
- 2015-02-17
- FDA published
- 2015-02-25
- Terminated
- 2015-11-23
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL