FDA Recall D-1076-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 593 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
Reason for recall
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Recall record
- Recall number
D-1076-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2015-03-06
- Classified by FDA Center
- 2015-05-13
- FDA published
- 2015-05-20
- Terminated
- 2016-10-19
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- MAGNESIUM SULFATE IN DEXTROSE
- Generic name(s)
- MAGNESIUM SULFATE IN DEXTROSE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-6727- Route(s)
- INTRAVENOUS