FDA Recall D-0668-2016

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Terminated 632 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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.

Lot / code: Lot: 53-113-JT, Exp 1NOV2016

Quantity: 213,600 bags

Reason for recall

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

Recall record

Recall number: D-0668-2016
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2016-01-05
Classified by FDA Center: 2016-02-16
FDA published: 2016-02-24
Terminated: 2017-09-28
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): MAGNESIUM SULFATE IN WATER
Generic name(s): MAGNESIUM SULFATE IN WATER
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-2050, 0409-6730, 0409-6729, 0409-4121, 0409-3164, 0409-5239
Route(s): INTRAVENOUS

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