Drug recall D-1137-2016

Class I Ongoing reported Jul 13, 2016

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.

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
88,500 vials
Distribution
Nationwide, United Arab Emirates, Kuwait, and Bahrain
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2016

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