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Magnesium Sulfate Potentially Mislabeled as Heparin Sodium Prompts Recall

Hospira, who has had a rash of recalls in the recent past, is recalling one lot of magnesium sulfate in 5% in dextrose injection USP, 10 mg/mL (NDC: 0409-6727-23), lot 42-120-JT, with an expiration date of December 1, 2015.

Reports of erroneous labeling of the barcode on the primary bag have prompted the recall. The incorrect barcode potentially reads: heparin sodium 2000 USP units/1000 mL in 0.9% sodium chloride inj. However, the barcode on the overwrap is correct, as well as the printed name on the overwrap and primary container.

The impacted lot was distributed from October 2014 to January 2015.

If in possession of the impacted product, immediate cessation of use and quarantine are recommended.

Currently, Hospira has not received any reports of adverse events.

 

Reference:

1. U.S. Food and Drug Administration. Hospira issues a voluntary nationwide recall of one lot of magnesium sulfate in 5% dextrose injection due to incorrect barcode labeling [press release]. www.fda.gov. 2015 Mar 6.

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