Drug recall D-0854-2016

Class III Ongoing reported May 25, 2016

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

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

Lots and codes

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.

Recall details

Recalling firm
Hospira Inc., Lake Forest, IL
Quantity
715,200 vials
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2016

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