Don't Use Discolored Norepinephrine Bitartrate Mixture, Compounder Warns

Article

Sterile drug compounder Pharmedium is voluntarily recalling multiple lots of norepinephrine bitartrate added to 0.9% sodium chloride in light of complaints from hospitals of a slight discoloration in the mixture.

Sterile drug compounder Pharmedium is voluntarily recalling multiple lots of norepinephrine bitartrate added to 0.9% sodium chloride in light of complaints from hospitals of a slight discoloration in the mixture.

The drug manufacturer’s prescribing information advises health care professionals not to use the product if it is discolored, as this is indicative of degradation and could decrease potency due to oxidation.

All of the 29 recalled lots of norepinephrine bitartrate 4 mg (16 mcg/mL) added to 0.9% sodium chloride in 250-mL Viaflex bags and 3 recalled lots of norepinephrine bitartrate 8 mg (32 mcg/mL) mixed exactly the same have expiration dates in February 2016.

Pharmedium e-mailed its distributors and customers on December 22, 2015, to inform them of this recall and request product quarantine and destruction. Hospital pharmacies stocking any recalled product are advised to stop using it and discard it per the hospital destruction policy.

As of December 31, 2015, Pharmedium has not received any reports of adverse effects related to this recall.

Any patients who believe they may have experienced negative side effects related to the product should speak with their health care provider or physician. Adverse reactions or quality problems associated with the product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

Norepinephrine bitartrate added to 0.9% sodium chloride is typically used for blood pressure control in certain hypotensive states.

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