Class III
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 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
This recall is currently active, issued May 25, 2016. It was issued by Hospira Inc..
- Company
- Hospira Inc.
- Recall Initiated
- March 23, 2016
- Posted
- May 25, 2016
- Recall Number
- D-0854-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 715,200 vials
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
Lot / Code Info
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.
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