PlainRecalls
FDA Drug Critical Class I Ongoing

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.

Reported: July 13, 2016 Initiated: March 23, 2016 #D-1137-2016

Product Description

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
88,500 vials
Distribution
Nationwide, United Arab Emirates, Kuwait, and Bahrain
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Hospira Inc.. Units affected: 88,500 vials.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 13, 2016. Severity: Critical. Recall number: D-1137-2016.