Hospira announced a voluntary nationwide recall of one lot of Aminosyn II 10%, Sulfite-Free.
This recall is due to one customer report where an unknown foreign particle was included in the injection port and in contact with the product. The foreign particle was confirmed to be human hair.
Aminosyn II 10% is an amino acid injection used as a source of nitrogen in nutritional support where oral nutrition cannot be tolerated.
The affected product is packaged in a 500mL flexible container with lot # 26-138-JT (may be followed by a “01”). The product has an NDC 0409-4164-03 with an expiration date of August 1, 2014. It was distributed between March—August 2013.
It is unlikely that the particulate could block the infusion of solution into the patient but if the particulate is able to pass through the intravenous catheter, it may result in local inflammation, phlebitis, low-level allergic response, or capillary occlusion.
Anyone with an existing inventory should stop use and distribution, and quarantine the product immediately. Stericycle can be contacted at (866) 737-4701 to arrange for the return of the product. Replacement products from other lots are available.
For more information call (866) 737-4701 or visit FDA.gov.