Hospira has initiated a voluntary nationwide user-level recall of one lot of Aminosyn II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT due to one confirmed customer report where a foreign particle—confirmed by Hospira as human hair—was included in the injection port and in contact with product. 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 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.