The product is a radiopharmaceutical agent used to determine blood cell concentration and volume in patients suspected of suffering from a disease known as Polycythemia rubra vera (PRV).
PRV is characterised by an excess of red blood cells as a result of a bone marrow abnormality. The disease, which is often also associated with excess white blood cells and platelets, can cause headaches, vertigo and spleen and liver enlargement.
Mallinckrodt’s owner Covidien, which just last month relocated its headquartered from Bermuda to Dublin, Ireland, explained why the voluntary Cr-51 recall is necessary.
The firm said that subpotent diagnostic agents can produce inaccurate results, leading to misdiagnosis and subsequent delays in treatment that increase the risk of embolus or stroke.
Covidien added that it has already recovered 84 per cent of the affected vials and said it is in the process of collecting the remaining product from customers in the Canada, Mexico and the US.
The firm also said it has not received news of either any patient complaints or reports of adverse events and stressed that, in financial terms, Cr-51 is a very minor part of its, adding that the recall will have only a minor impact.
Radiopharmaceuticals have been a key focus of the $100m (€74m) manufacturing capacity expansion programme that Covidien unveiled in the third quarter last year.
In October the firm announced plans to add 5,000 sq ft of dedicated production, storage and handling space at its Maryland Heights plant in St Louis, Missouri.