Hospira recalls two products due to human hair, potentially life-threatening conditions
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The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
Hospira has not received reports of any adverse events.
Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. However, the likelihood of these risks is low as there is no evidence indicating that IV injection of inert particles results in harm to patients when only a small amount over a limited period of time is administered.
Delay of therapy may occur due to observation of particulate at the point of care. However, this delay is likely to be of negligible clinical significance as this medication is administered by a health care provider and remediation is readily available.
This lot was distributed nationwide from December 2014 through January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., due to confirmed customer reports of an incorrect barcode on the primary bag labeling.
The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.
If the incorrect barcode on Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/ mL is not detected prior to dispensing or administration to a patient, and the product is administered based on the printed name, patient harm is unlikely since the barcode on the overwrap and readable text on the primary container and overwrap are correct.
However, if detected, there is the potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Administration of the magnesium sulfate drug product to a patient who is prescribed heparin and in whom the magnesium sulfate is contraindicated can result in serious adverse events related to the drug’s pharmacologic action and may require medical intervention.
Although serious in nature, the likelihood of this risk to occur is low due to the high detectability of this nonconformance. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. ■