Why manufacturer is recalling hospital blood pressure drug

January 4, 2016

Hospital pharmacies need to check their supplies of norepinephrine after PharMEDium Services in Lake Forest, Ill., voluntarily recalled several lots of Norepinephrine Bitartrate. The product is used to control blood pressure in certain acute hypotensive states.

Hospital pharmacies need to check their supplies of norepinephrine after PharMEDium Services in Lake Forest, Ill., voluntarily recalled several lots of Norepinephrine Bitartrate. The product is used to control blood pressure in certain acute hypotensive states.

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In late December, PharMEDium recalled 29 lots of 4-mg Norepinephrine Bitartrate (16 μg/mL) added to 0.9% Sodium Chloride in 250-mL Viaflex Bag and 3 lots of 8 mg. Norepinephrine Bitartrate (32 μg/mL) added to 0.9% Sodium Chloride in 250-mL Viaflex Bag distributed to hospitals.

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“We have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture. The drug manufacturer's prescribing information advises not to use the product if it is discolored,” according to a statement from the company. Discoloration indicates degradation and could result in decreased potency, due to oxidation of Norepinephrine Bitartrate.

While decreased potency may result in a delay of achieving desired therapeutic effect, PharMEDium Services has not received any reports of adverse events related to the recall.

Meanwhile, hospital pharmacies that have the recalled Norepinephrine Bitartrate products should stop using and discard per the hospital destruction policy, PharMEDium said. “Hospitals that may have shared these products with other hospitals should contact those hospitals that received the products.”

A full listing of the recalled lots can be found here: http://www.fda.gov/Safety/Recalls/ucm479677.htm.

Hospitals or other healthcare providers with questions regarding the recall can contact PharMEDium Services at 847-457-2244 or email quality1@pharmedium.com.

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