Drug 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.
D-1137-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 73855
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 88,500 vials
- Official record key
drug-enforcement:D-1137-2016
Official wording
Reason: Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Code information: Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
Distribution pattern: Nationwide, United Arab Emirates, Kuwait, and Bahrain
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter