FDA recall record

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL recall — FDA D-0668-2016

Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

Class Iclassification
D-0668-2016official record ID
Feb 24, 2016report date

Recall record at a glance

Official recordD-0668-2016
CategoryDrug Recalls
ClassificationClass I
FDA record statusTerminated
Recalling firmHospira Inc.
Report dateFeb 24, 2016
Recall initiation dateJan 5, 2016
Quantity213,600 bags
LocationLake Forest, IL, United States

Official product description

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

Why the product was recalled

Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

Distribution information

Nationwide

How to read the classification

FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Press Release.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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