Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. To date, Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. This recall is being conducted as a precautionary measure.
The brass particulate was identified as containing copper, zinc and lead. If the particulate is undetected, there is a potential for delay in therapy, or if administered, solution containing brass particulate may result in occlusion of small blood vessels. In a worst-case scenario, copper toxicity may potentially result in hemolysis and liver toxicity, including hepatic necrosis which may be fatal.
The product is used as a source of water and electrolytes and is packaged in a 1000 mL flexible container, lot number 25-037-JT (the lot number may be followed by a -01 or -90), with an expiration date of January 1, 2015. The affected lot was distributed nationwide between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies.
http://www.fda.gov/Safety/Recalls/ucm345963.htm
