Reported May 25, 2016 · 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…
Hospira Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
Magnesium Sulfate InjUSP 50%10 g/20 mL (0.5 g/mL)(4 mEq Magnesium/mL20 mL Single-dose vialpackaged in 25 vials per boxRx OnlyHospiraIncLake ForestIL 60045NDC 0409-2168-02barcode (01) 2 030409 216802 5
- Lot codes and dates
- Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
- Amount recalled
- 715,200 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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