Recalls

Hospira recalls electrolyte solution due to possible contamination

Recalls Hospira logo1 Hospira recalls electrolyte solution due to possible contaminationHospira is recalling containers of sodium chloride injection used as a source of water and electrolytes for patients with various conditions. The recall is based on a confirmed customer report in which four individual flexible containers of the solution were found to be contaminated with polyester fiber, nylon fiber, cotton fiber and nitrocellulous fiber. Hospira is investigating to determine the root cause of the contamination.

Sodium chloride injection is used to treat conditions such as dehydration and metabolic alkalosis, as a priming solution in hemodialysis procedures and blood transfusions, and to aid in the infusion of drug additives. If the tainted solution is used on a patient, this may result acutely in local inflammation, phlebitis, and/or generalized low-level allergic response to the particulate and/or embolization to other organs in the body. Chronically, following sequestration, granulomatous formation in the lungs is possible.

The recall involves Hospira sodium chloride injection 0.9 percent USP, 100mL flexible containers with the lot number 05-201-JT with an expiration date of May 1, 2013. The product was distributed across the country between May 2011 and August 2011 to wholesale distributors, hospitals and pharmacies.

The product was distributed to the following states: Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming.

Earlier this month, Hospira recalled a different lot of sodium chloride injection – 25-037-JT – because tiny brass particles were found floating in an container of the solution. The particulate was identified as containing copper, zinc and lead.

In both recalls, customers were instructed to stop using the products and quarantine the solution immediately.

Any side effects or quality control issues with this or any other product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report/htm.

Source: FDA