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.

FDA recall notice · announced July 13, 2016 · Hospira

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide, United Arab Emirates, Kuwait, and Bahrain
Lot/code information: Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
Quantity: 88,500 vials
Status: Ongoing
Products in this recall event:
- 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, barc (D-1137-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.