Hospira Inc. recalls 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 via…

Recall date

March 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0854-2016

FDA classification

Class III

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago

Why it was recalled

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Class III means the product violates regulations but is not likely to cause harm.

What 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.