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.
Reported: May 25, 2016 Initiated: March 23, 2016 #D-0854-2016
Product Description
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.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 715,200 vials
- Distribution
- Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 715,200 vials.
Why was this product recalled? ▼
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2016. Severity: Low. Recall number: D-0854-2016.
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