Hospira is initiating a voluntary nationwide user-level recall of one lot of Aminosyn™ II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation.
Aminosyn II is combined with dextrose, electrolytes, trace elements, vitamins and, in the case of total nutrient admixtures, fat emulsion as part of parenteral nutrition therapy. The FDA Safety Alert April 18, 1994 Hazards of Precipitation Associated with Parenteral Nutrition indicates a 0.22 micron air eliminating filter be used with non-lipid containing admixtures and a 1.2 micron air eliminating filter for lipid containing admixtures. If the particulate matter is not detected until the point of care, there may be a delay in therapy. In the event that the particulate was not observed, the particulate identified theoretically would not be able to pass through the intravenous catheter or an intravenous infusion. It is also unlikely that the particulate could block the infusion of solution into the patient.
In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
Aminosyn II 10% is an amino acid injection used as a source of nitrogen in the nutritional support of patients where oral nutrition cannot be tolerated and is packaged in a 500 mL flexible container, lot number 26-138-JT (the lot number may be followed by a 01) with an expiration date of August 1, 2014. The affected lot was distributed nationwide between March 2013 and August 2013 to wholesalers/distributors, hospitals and pharmacies.
