FDA Recall D-263-2013
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1050 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 60045, NDC 0409-7929-09.
Reason for recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Recall record
- Recall number
D-263-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-10-05
- Classified by FDA Center
- 2013-04-17
- FDA published
- 2013-04-24
- Terminated
- 2015-08-21
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL