Critical Care Drug Recalled After Discoloration Complaints
PharMEDium Services, LLC announced a voluntary recall of 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag.
The recall was initiated after hospitals complained that some products showed a slight discoloration in the admixture. The prescribing information recommends to not use the product if it is discolored. Discoloration may suggest product degradation and can lead to reduced potency due to oxidation of norepinephrine bitartrate; reduced potency can result in a delay of achieving desired therapeutic effect.
Norepinephrine Bitartrate is a sympathomimetic indicated for controlling blood pressure in certain acute hypotensive states and is supplied in 250mL Viaflex Bags.
Hospitals in possession of the affected lots should stop use and discard following the hospital destruction policy. Further, institutions that may have shared these products with other hospitals should contact those hospitals.
The full list of affected products can be found here.For more information call (847) 457-2244 or visit FDA.gov.