ISSUE: Hospira initiated a voluntary nationwide user-level recall of one lot (Lot# 26-138-JT ) of Aminosyn II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03 due to one report of an unknown foreign particle in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
BACKGROUND: 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. Lot number 26-138-JT has an expiration date of August 1, 2014 and was distributed nationwide between March 2013 and August 2013 to wholesalers/distributors, hospitals and pharmacies.
RECOMMENDATION: Anyone with an existing inventory of the affected Lot# 26-138-JT should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-737-4701 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product.
[08/30/2013 - Press Release - Hospira, Inc.]