FDA Recall D-1137-2016

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Ongoing 3704 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Lot / code: Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.

Quantity: 88,500 vials

Reason for recall

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Recall record

Recall number: D-1137-2016
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide, United Arab Emirates, Kuwait, and Bahrain
Recall initiated: 2016-03-23
Classified by FDA Center: 2016-07-06
FDA published: 2016-07-13
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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